Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05451290
Collaborator
(none)
30
1
1
36
0.8

Study Details

Study Description

Brief Summary

This is a phase II open-label, one-arm, multicenter study aimed to explore the efficacy and safety of perioperative (neoadjuvant and adjuvant) treatment for patients with advanced biliary tract carcinoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur
Phase 2

Detailed Description

Enrolled participants should be treated with neoadjuvant camrelizumab and apatinib and GEMOX, after surgery, be treated with adjuvant camrelizumab and tegafur.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Camrelizumab Plus Apatinib Combined With GEMOX (Gemcitabine and Oxaliplatin ) in the Perioperative Treatment of Locally Advanced Biliary Tract Malignancies: A Prospective, Multicenter, Phase Ⅱ Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

Drug: Camrelizumab, apatinib, gemcitabine, oxaliplatin, tegafur
Perioperative treatment: camrelizumab plus apatinib in combination with GEMOX 2-4 cycles (neoadjuvant); camrelizumab plus tegafur up to 1 year (adjuvant).
Other Names:
  • surgery
  • Outcome Measures

    Primary Outcome Measures

    1. R0 resection rate [up to 2 years]

      The proportion of patients with negative resection margin among patients undergoing surgery

    2. 1-year event-free survival (EFS) rate [up to 1 year]

      The proportion of patients with first documented recurrence or disease progression as determined by the investigator, or death from any cause, whichever occurs first.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Informed consent document must be signed.

    2. Aged 18-75 years old, both genders.

    3. Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before.

    4. An Eastern Cooperative Oncology Group performance status of 0 to 1.

    5. Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion.

    6. The function of vital organs meets the following requirements:

    the blood ANC count≥1.5x109 /L; hemoglobin ≥ 90 g/L,the blood platelet count≥80 x109 /L, total bilirubin ≤ 1.5 x ULN, ALT and AST ≤3 x ULN(< 5 x ULN for patients with live metastasis), serum creatinine≤1.5 x ULN, endogenous creatinine clearance rate ≥45ml/min.

    1. At least 1 measurable lesion as defined by RECIST 1.1.

    2. Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication.

    3. Subjects should have good compliance and cooperate with the follow-up.

    Exclusion Criteria:
    1. Subject has any active autoimmune disease or history of autoimmune disease will not be included, nor will patients with active tuberculosis or hepatitis or HIV.

    2. Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled.

    3. Subjects with active malignancies other than BTC within 5 years should be excluded, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and superficial bladder cancer [Ta, Tis & T1] and papillary thyroid cancer.

    4. Any unstable systemic disease which might need systemic treatment should not be enrolled (including active infection, liver or renal disease, metabolic disease, acute cerebral infarction or hemorrhage), or serious co-morbidities that by the judgment of the investigator, may compromise the patient's safety or impair the patient's ability to complete the study.

    5. Subjects who have significant cardiovascular events should not be enrolled, for example: congestive heart failure > NYHA class 2, unstable angina, active coronary artery disease (CAD) (only allow the subjects with presence of myocardial infarction more than 1 year prior to study); severe arrhythmias in need of treatment (only allow those been treated with β-blockers or digoxin) or uncontrolled hypertension.

    6. Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled.

    7. Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled.

    8. Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided.

    9. Subjects who had used PD-1/PD-L1 or other antitumor immunotherapeutic agents prior to enrollment should be avoided.

    10. The following subjects should be avoided: pregnant or lactating women; those who have childbearing potential and unwilling or unable to use effective contraception measures.

    11. Other circumstances that could affect the trial or the result of the study judged by the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05451290
    Other Study ID Numbers:
    • IIT20220057C
    First Posted:
    Jul 11, 2022
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2022