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Neoadjuvant Finotonlimab Plus TP Regimen in Locally Advanced INI-1-Deficient Sinonasal Carcinoma (SDSC-IO-TP)

3. november 2026 opdateret af: Quan Liu, Eye & ENT Hospital of Fudan University

Neoadjuvant Finotonlimab Plus TP Regimen in Locally Advanced INI-1 (SMARCB1)-Deficient Sinonasal Carcinoma: A Prospective, Multicenter, Single-Arm Phase II Clinical Study

This is a prospective, multicenter, single-arm phase 2 study in adults with locally advanced (T3/T4) INI-1 (SMARCB1)-deficient sinonasal carcinoma, a very rare and aggressive cancer of the nasal cavity and sinuses. This cancer often invades the skull base, eyes, nerves, and surrounding critical structures, making surgery difficult and potentially disabling. Current standard treatment is usually surgery followed by radiotherapy, but complete removal is often difficult and recurrence is common. Standard chemotherapy before surgery has shown limited tumor shrinkage, so better pre-surgical treatment is urgently needed.

The purpose of this study is to find out whether giving an immunotherapy drug, finotonlimab, together with standard chemotherapy (paclitaxel plus cisplatin, the "TP" regimen) before surgery can shrink the tumor and improve treatment results. Finotonlimab is a PD-1 inhibitor that may help the immune system attack the cancer, and it is being given together with chemotherapy because the two treatments may work better in combination. All participants will receive 2 cycles of this combined treatment (each cycle is 21 days), followed by imaging tests to measure tumor response. If the tumor is considered removable, participants will then undergo surgery and, after recovery, standard postoperative radiotherapy.

The main question this study is trying to answer is: how many participants experience significant tumor shrinkage (objective response, defined as complete or partial response) after 2 cycles of neoadjuvant finotonlimab plus TP chemotherapy, as assessed by blinded independent imaging review using RECIST v1.1. The study will also look at safety, the rate of complete surgical removal (R0 resection), pathological response, disease-free and overall survival, quality of life, and whether important organs such as the eye can be preserved. About 20 participants will be enrolled across multiple centers. This study is expected to provide the first prospective evidence for this combination in this rare cancer and may help establish a new treatment option before surgery.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This phase 2 study is designed to evaluate the efficacy and safety of neoadjuvant finotonlimab combined with TP chemotherapy in patients with locally advanced INI-1 (SMARCB1)-deficient sinonasal carcinoma. INI-1 deficiency defines a rare, aggressive subtype of sinonasal carcinoma with a high propensity for skull base invasion and limited response to conventional induction chemotherapy. The study hypothesis is that adding PD-1 blockade to standard TP chemotherapy will increase the preoperative objective response rate, facilitate tumor downstaging, improve R0 resection, and potentially reduce surgical morbidity while preserving organ function.

Approximately 20 eligible participants will be enrolled across multiple centers. All participants will receive 2 cycles of neoadjuvant therapy every 21 days: finotonlimab 200 mg intravenously on day 1, followed by paclitaxel 135-175 mg/m² on day 1 and cisplatin 70-75 mg/m² on days 1-3, with standard premedication, hydration, and antiemetic support. After 2 cycles, tumor response will be assessed by contrast-enhanced MRI of the skull base and chest CT, with independent blinded central review using RECIST v1.1. Participants with complete response, partial response, or stable disease will proceed to definitive surgery aiming for R0 resection, followed by postoperative intensity-modulated radiotherapy (60-66 Gy in 30-33 fractions) after adequate wound healing. Participants with progressive disease will discontinue the study regimen and receive salvage therapy as determined by the multidisciplinary team.

The primary endpoint is objective response rate after 2 cycles of neoadjuvant therapy, assessed by blinded independent central review. Secondary assessments include disease control rate, R0 resection rate, major pathological response, pathological complete response, disease-free survival, overall survival, safety and tolerability according to CTCAE v5.0, surgery- and radiotherapy-related complications, quality of life using EORTC QLQ-C30 and QLQ-H&N35, and organ preservation rate. Exploratory analyses will evaluate the association of PD-L1 CPS, Ki-67, TP53 mutation status, and serial circulating tumor DNA dynamics with treatment response and recurrence risk, and will explore baseline clinical features such as T stage and cranial nerve involvement as potential predictors of benefit.

This study is expected to provide the first prospective multicenter evidence for neoadjuvant PD-1 blockade combined with TP chemotherapy in this ultra-rare sinonasal malignancy. If positive, the results may support a new preoperative treatment paradigm aimed at improving resectability and functional outcomes, and will inform future larger studies.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
20

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200031
        • Rekruttering
        • Eye & ENT Hospital of Fudan University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 18-75 years, male or female.
  2. Complete loss of nuclear INI-1 (SMARCB1) expression in tumor cells confirmed by central pathology immunohistochemistry, with a pathological diagnosis of primary malignant tumor of the sinonasal cavity and skull base.
  3. No prior radiotherapy of any type, including proton/heavy-ion radiotherapy or intensity-modulated radiotherapy.
  4. AJCC 8th edition stage T3, T4a, or T4b; N0-N2 lymph node metastasis is allowed; isolated distant metastases assessed by MDT as stable and amenable to concurrent local treatment are allowed; extensive multiple distant metastases are excluded.
  5. MDT assessment indicates extensive local invasion of the skull base and/or orbit, high difficulty for direct surgery, high risk of residual disease, and suitability for neoadjuvant downstaging.
  6. ECOG performance status 0-1 and expected survival ≥6 months.
  7. Baseline laboratory values meet treatment safety standards: absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L; ALT/AST ≤2.5 × ULN; total bilirubin ≤1.5 × ULN; serum creatinine ≤1.5 × ULN; creatinine clearance ≥60 mL/min; LVEF ≥50%; and no significant thyroid dysfunction.
  8. Voluntary participation with full understanding of benefits and risks, and signing of two copies of the informed consent form.

Exclusion Criteria:

  1. Prior use of PD-1/PD-L1 inhibitors, taxane chemotherapy, or platinum-based chemotherapy.
  2. History of severe allergy to finotonlimab, paclitaxel, cisplatin, or any of their excipients.
  3. Active autoimmune disease, interstitial lung disease, active tuberculosis, or uncontrolled severe infection.
  4. Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, or severe hepatic or renal failure.
  5. History of another malignancy within 5 years, except adequately treated basal cell skin cancer or carcinoma in situ.
  6. Pregnant or breastfeeding women.
  7. Men or women of childbearing potential who are unwilling to use adequate contraception during treatment and for 6 months after the end of treatment.
  8. Participation in another anticancer clinical trial within 30 days before enrollment.
  9. Psychiatric disorders, poor compliance, or inability to complete follow-up.
  10. Extensive multiple intracranial metastases or inability to tolerate systemic treatment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Neoadjuvant Finotonlimab Plus TP Chemotherapy

All participants are enrolled in this single experimental arm and receive the same study-specified treatment sequence. Participants first receive 2 cycles of neoadjuvant therapy, with each cycle lasting 21 days: finotonlimab 200 mg by intravenous infusion on day 1; paclitaxel 135-175 mg/m² by intravenous infusion on day 1; and cisplatin 70-75 mg/m² by intravenous infusion on days 1-3. Standard premedication, hydration, antiemetic prophylaxis, and supportive care are given according to institutional practice. After 2 cycles, tumor response is assessed by contrast-enhanced MRI of the skull base and chest CT with blinded independent central review using RECIST v1.1. Participants with complete response, partial response, or stable disease then undergo definitive surgery aiming for R0 resection. Postoperative intensity-modulated radiotherapy (IMRT) of 60-66 Gy in 30-33 fractions is planned to start 4-6 weeks after surgery, once wound healing and general condition permit. Participants with
Medicin: Finotonlimab

Finotonlimab is an anti-PD-1 monoclonal antibody administered as part of neoadjuvant therapy. It is given intravenously at a fixed dose of 200 mg on day 1 of each 21-day cycle, for a total of 2 cycles. It is infused before paclitaxel and cisplatin on the same day. This is the experimental immunotherapy component of the study regimen.

Medicin: Paclitaxel

Paclitaxel is a standard cytotoxic chemotherapy agent administered as part of the neoadjuvant TP regimen. It is given by intravenous infusion over 3 hours on day 1 of each 21-day cycle, at a dose of 135-175 mg/m², for a total of 2 cycles. Standard premedication (dexamethasone, diphenhydramine, and cimetidine or an equivalent H2 blocker) is given before infusion to prevent hypersensitivity reactions. Paclitaxel is administered after finotonlimab and before cisplatin.

Medicin: Cisplatin

Cisplatin is a standard platinum-based chemotherapy agent administered as part of the neoadjuvant TP regimen. It is given by intravenous infusion at a dose of 70-75 mg/m² on days 1-3 of each 21-day cycle, with the total dose for the cycle divided across the three days, for a total of 2 cycles. It is administered after paclitaxel on day 1. Standard hydration, diuresis, and electrolyte supplementation (potassium and magnesium) are provided. This divided-day schedule is used to reduce acute nephrotoxicity and severe emesis associated with single high-dose cisplatin.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: After completion of 2 cycles of neoadjuvant therapy (each cycle is 21 days; response assessment performed approximately 3 weeks after the last dose of cycle 2)

Objective response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant finotonlimab plus TP chemotherapy. Tumor response is assessed by contrast-enhanced MRI of the skull base and chest CT, and evaluated by a blinded independent central review (BICR) according to RECIST v1.1. ORR is calculated as (CR + PR) divided by the number of participants in the full analysis set (all enrolled participants who signed informed consent and received at least 1 dose of study treatment). The 95% confidence interval will be estimated using the Clopper-Pearson exact method.
After completion of 2 cycles of neoadjuvant therapy (each cycle is 21 days; response assessment performed approximately 3 weeks after the last dose of cycle 2)

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease Control Rate (DCR)
Tidsramme: Approximately 9 weeks after the first dose of neoadjuvant therapy (after 2 cycles of 21 days each), consistent with the primary ORR assessment time point.

DCR is defined as the proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) after 2 cycles of neoadjuvant finotonlimab plus TP chemotherapy, assessed by blinded independent central review (BICR) using RECIST v1.1. DCR is calculated as (CR + PR + SD) divided by the number of evaluable participants.
Approximately 9 weeks after the first dose of neoadjuvant therapy (after 2 cycles of 21 days each), consistent with the primary ORR assessment time point.
R0 Resection Rate
Tidsramme: At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy)

R0 resection rate is defined as the proportion of participants who undergo surgery and achieve microscopically negative surgical margins (R0), as confirmed by central pathology review. The denominator is all participants who undergo definitive surgery.
At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy)
Disease-Free Survival (DFS)
Tidsramme: From the date of surgery until the date of first documented recurrence, metastasis, or death from any cause, assessed up to 3 years after surgery.

DFS is defined as the time from the date of surgery to the date of local recurrence, distant metastasis, or death from any cause, whichever occurs first. DFS will be estimated using the Kaplan-Meier method.
From the date of surgery until the date of first documented recurrence, metastasis, or death from any cause, assessed up to 3 years after surgery.
Overall Survival (OS)
Tidsramme: From the date of enrollment until the date of death from any cause, assessed up to 3 years after enrollment.

OS is defined as the time from enrollment (or randomization, if applicable) to the date of death from any cause. Participants alive at the last follow-up will be censored at that date. OS will be estimated using the Kaplan-Meier method.
From the date of enrollment until the date of death from any cause, assessed up to 3 years after enrollment.
Major Pathological Response (MPR) Rate
Tidsramme: At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy).

MPR is defined as the proportion of participants whose surgically resected specimens contain ≤10% viable tumor cells, as assessed by central pathology review. The denominator is all participants who undergo definitive surgery and have evaluable pathological specimens.
At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy).
Pathological Complete Response (pCR) Rate
Tidsramme: At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy).

pCR is defined as the proportion of participants whose surgically resected specimens contain no viable tumor cells, as assessed by central pathology review. The denominator is all participants who undergo definitive surgery and have evaluable pathological specimens.
At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy).
Incidence and Severity of Adverse Events During Neoadjuvant Therapy
Tidsramme: From the first dose of neoadjuvant therapy until 30 days after the last dose of neoadjuvant therapy (approximately 3 months).

All adverse events (AEs), Grade ≥3 AEs, and serious adverse events (SAEs) occurring during neoadjuvant therapy will be recorded and graded according to CTCAE v5.0. The type, incidence, and outcome of each event will be summarized descriptively.
From the first dose of neoadjuvant therapy until 30 days after the last dose of neoadjuvant therapy (approximately 3 months).
Incidence of Surgery- and Radiotherapy-Related Complications
Tidsramme: From the date of surgery until 12 months after completion of postoperative radiotherapy.

The incidence of prespecified complications will be recorded, including cerebrospinal fluid leak, intracranial infection, cranial nerve injury, major hemorrhage, trismus, and radiation-induced brain injury. Complications will be documented from the surgical record and during the postoperative radiotherapy and follow-up periods
From the date of surgery until 12 months after completion of postoperative radiotherapy.
Change in Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35
Tidsramme: Baseline, before surgery (after neoadjuvant therapy), after surgery, and every 6 months during follow-up, assessed up to 3 years after enrollment.

Quality of life will be assessed using the EORTC QLQ-C30 (Version 3.0) and the head and neck module QLQ-H&N35. Scores for functional scales, symptom scales, and the global health status/QoL scale will be collected and the change from baseline will be summarized at each prespecified time point.
Baseline, before surgery (after neoadjuvant therapy), after surgery, and every 6 months during follow-up, assessed up to 3 years after enrollment.
Organ Preservation Rate
Tidsramme: At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy).

Organ preservation rate is defined as the proportion of participants who undergo definitive surgery without orbital exenteration or extensive craniofacial/maxillary resection. Organ preservation status will be determined from the surgical record and multidisciplinary team assessment.
At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Eye & ENT Hospital of Fudan University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
28. september 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
31. december 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
31. december 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
3. november 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
3. november 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
3. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 2026211-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared. This is an investigator-initiated study in an ultra-rare cancer, where even limited demographic and clinical data could risk re-identification. The informed consent and ethics approval restrict use of biological samples and data to this specific research; samples will not be transferred to third parties and will be destroyed after 5 years. The study does not have infrastructure for external data access. If the sharing plan changes, this record will be updated accordingly.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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