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Sintilimab Combined With Anlotinib Therapy for Initially Unresectable Non-small Cell Lung Cancer

23. marts 2022 opdateret af: YueJuan Cheng, Peking Union Medical College Hospital

Sintilimab Combined With Anlotinib Therapy for Patients With Initially Unresectable Stage II-III Non-small Cell Lung Cancer: A Prospective, Single-arm Study

Concurrent or sequential chemoradiotherapy has been recommended as the standard treatment for locally advanced and unresectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. PD-1/PD-L1 inhibitors have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents have also been used for the first-line treatment of advanced or metastatic NSCLC. Therefore, we designed this single-arm clinical trial, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Concurrent or sequential chemoradiotherapy is the standard treatment for patients with locally advanced NSCLC, but patients receiving chemoradiotherapy have limited improvement in prognosis and are almost impossible to achieve a radical cure. Considering the excellent effect of immunotherapy and anti-angiogenesis therapy in NSCLC, we designed this single-arm clinical study, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC, in order to enable patients to achieve further surgical treatment and prolonged survival.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

93

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

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

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. According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage II-III C) NSCLC confirmed by histology who are initially unable to undergo surgery and concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.
  2. Age ≥18 years and ≤75 years.
  3. ECOG PS score: 0 to 1.

  4. The main organs function is normal, that is, the following criteria met:

    1. Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109 /L, platelet count≥100 ×109 /L, hemoglobin ≥90g/L [no blood transfusion or no erythropoietin (EPO) dependence within 7 days before enrollment];
    2. Biochemical test results should meet the following criteria: BIL < 1.25 times the upper limit of normal value (ULN); ALT and AST < 2.5 × ULN; in case of liver metastases, ALT and AST < 5 × ULN; Cr ≤1.5×ULN or creatinine clearance (CCr) ≥60ml/min; Coagulation function is good, INR and PT ≤1.5 × ULN;
    3. The oxygen saturation of the finger tip ≥ 92% both at rest and during walking (without oxygen inhalation).
  5. The life expectancy ≥12 weeks.
  6. Signed and dated informed consent.

Exclusion Criteria:

  1. Subjects at risk of massive hemoptysis or with blood in sputum, including but not limited to tumor lesions no more than 5 mm away from large vessels, tumors invading large vessels, and obvious lung cavity/necrotizing tumors.
  2. Small cell lung cancer (including mixed small cell and non-small cell lung cancer) or central squamous cell carcinoma.
  3. With driver mutation (EGFR/ALK/ROS1).
  4. With uncontrollable hypertension (systolic pressure > 160 mmHg, diastolic pressure > 100 mmHg) even receiving antihypertensive drug therapy.
  5. Has an active autoimmune disease, history of allogeneic stem cell transplantation or organ transplantation that has required systemic treatment. Replacement therapy is not considered a form of systemic treatment and is allowed.
  6. Has an active infection requiring systemic therapy.
  7. Has other malignant tumors (except radical cervical carcinoma in situ, non-melanoma skin cancer, etc.) or concomitant diseases that seriously endanger the patients or affect the patients completing the study at the same time.
  8. With immunodeficiency status, including but not limited to HIV infection and primary immunodeficiency diseases.
  9. Previously treated with ICIs.
  10. Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study 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
Intervention / Behandling
Eksperimentel: Experimental arm

Sintilimab will be given intravenously at a dose of 200mg every 21 days. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.

Tumor evaluation will be conducted after treatment of the tested regimen every 2 cycles. Subsequent treatment will be determined based on the evaluation results: If the patients are not suitable for radical surgery, but the result of efficacy evaluation is CR, PR, or SD, they can continue to receive the tested regimen. If the patients are still not suitable for radical surgery after 6 cycles of the tested regimen, the standard first-line or immunotherapy after chemoradiotherapy or radiotherapy will be given. If patients are eligible for radical surgery, surgery will be performed within 4 weeks after completion of the last tested regimen.
Medicin: Sintilimab
Sintilimab will be given intravenously at a dose of 200mg every 21 days.
Andre navne:
  • IBI308
  • Tyvyt
Medicin: Anlotinib
Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
Andre navne:
  • AL3818
  • Anlotinib hydrochlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Surgical conversion rate
Tidsramme: 18 weeks from the initiation of the tested regime therapy
The surgical conversion rate was defined as the proportion of subjects with the successful conversion over all subjects who received the tested regime.
18 weeks from the initiation of the tested regime therapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: 18 weeks from the initiation of the tested regime therapy
ORR is defined as the percentage of participants who have the best overall response (BOR) of complete response (CR) or partial response (PR) assessed based on RECIST 1.1.
18 weeks from the initiation of the tested regime therapy
R0 resection rate
Tidsramme: within 28 working days after operation
R0 resection rate is defined as the complete resection rate of all tumor under microscope.
within 28 working days after operation
Major pathological response rate
Tidsramme: within 28 working days after operation
Major pathological response rate is defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%).
within 28 working days after operation
Pathological complete response rate
Tidsramme: within 28 working days after operation
Pathological complete response rate is defined as the percentage of patients who achieved a pathological complete response (residual tumor = 0%).
within 28 working days after operation
Overall survival (OS)
Tidsramme: 2 years from the initiation of the tested regime therapy
OS is measured from the time from the treatment onset (date of first study dose) until the date of death from any cause.
2 years from the initiation of the tested regime therapy
Progression-free survival (PFS)
Tidsramme: 2 years from the initiation of the tested regime therapy
PFS is measured from the time from the treatment onset (date of first study dose) until the date of tumor progression or death from any cause.
2 years from the initiation of the tested regime therapy
Disease-free survival (DFS)
Tidsramme: 2 years from the initiation of the tested regime therapy
DFS is measured from the time from radical surgery until the date of tumor progression or death from any cause.
2 years from the initiation of the tested regime therapy
Treatment-related adverse events
Tidsramme: 3 months from the end of the tested regime therapy
Incidence and grade of treatment-related adverse events assessed based on CTCAE 5.0
3 months from the end of the tested regime therapy

Samarbejdspartnere og efterforskere

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

Sponsor

Peking Union Medical College Hospital

Samarbejdspartnere

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Xinda Biopharmaceutical Group

Efterforskere

  • Ledende efterforsker: Chunmei Bai, Professor, Peking union medical colloge hospital

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 (Forventet)

1. april 2022

Primær færdiggørelse (Forventet)

1. april 2024

Studieafslutning (Forventet)

1. april 2026

Datoer for studieregistrering

Først indsendt

21. marts 2022

Først indsendt, der opfyldte QC-kriterier

23. marts 2022

Først opslået (Faktiske)

1. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS-3340

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD-delingstidsramme

Data will be available within 1 year of study completion

IPD-delingsadgangskriterier

Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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