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Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer(Phase II)

Efficacy of Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer: A Single-Arm, Single-Center Phase II Trial

This study is a single-arm, single-center prospective clinical study that will evaluate the clinical feasibility and efficacy of immunotherapy combined with chemotherapy in the neoadjuvant treatment of ovarian cancer, in order to explore the progression-free survival of the study population.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

49

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Studiesteder

      • Shanghai, Kina, 201101
        • Obstetrics and Gynecology 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

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, FIGO 2014 stage III-IV disease;
  2. Female patients aged 18 to 75 years;
  3. Willing and able to provide written informed consent and comply with study visits and protocol-specified procedures;
  4. Candidates for cytoreductive surgery (debulking surgery);
  5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  7. Estimated life expectancy of at least 6 months;
  8. Women of childbearing potential must agree to use effective contraception during the study period, and a negative serum or urine pregnancy test is required prior to enrollment;
  9. Adequate organ function.

Exclusion Criteria:

  1. Histological subtypes other than epithelial ovarian carcinoma, including mucinous carcinoma and clear cell carcinoma.
  2. Pregnant women or patients whose most recent pregnancy was terminated within 2 weeks prior to screening.
  3. Clinically significant hydronephrosis not amenable to stenting or nephrostomy, or presence of CNS metastases or carcinomatous meningitis.
  4. History of other malignancies within 3 years, except for adequately treated curable cancers (e.g., skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, or carcinoma in situ of the breast).
  5. Prior treatment with immune checkpoint inhibitors or other immunomodulatory anticancer therapies.
  6. Major surgery within 4 weeks before study treatment, or planned major surgery during the study period.
  7. Severe cardiovascular or cerebrovascular disease.
  8. Unresolved ≥ Grade 2 toxicity (CTCAE v5.0) from prior anticancer therapy, excluding alopecia.
  9. Known hypersensitivity to study drugs or their components.
  10. Any condition that may compromise patient safety or interfere with study evaluation, as judged by the investigator.

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
Intervention / Behandling
Eksperimentel: Experimental Arm
Participants will receive immunotherapy combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by interval cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively according to pathological results.
Participants will receive immunotherapy (iparomlimab plus tuvonralimab) combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively based on pathological results.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
median progression-free survival (PFS)
Tidsramme: From first dose of study treatment to disease progression or death from any cause, with patients followed until disease progression, death, or last disease, assessment assessed up to 60 months.
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method.
From first dose of study treatment to disease progression or death from any cause, with patients followed until disease progression, death, or last disease, assessment assessed up to 60 months.

Samarbejdspartnere og efterforskere

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

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 (Anslået)

6. juni 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

14. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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 .

Kliniske forsøg med Livmoderhalskræft

Kliniske forsøg med Neoadjuvant Therapy Plus Surgery

3
Abonner