Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer
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 |
|---|---|---|
|
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
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:
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Outcome Measures
Primary Outcome Measures
- R0 resection rate [up to 2 years]
The proportion of patients with negative resection margin among patients undergoing surgery
- 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
Inclusion Criteria:
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Informed consent document must be signed.
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Aged 18-75 years old, both genders.
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Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before.
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An Eastern Cooperative Oncology Group performance status of 0 to 1.
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Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion.
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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.
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At least 1 measurable lesion as defined by RECIST 1.1.
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Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication.
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Subjects should have good compliance and cooperate with the follow-up.
Exclusion Criteria:
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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.
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Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled.
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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.
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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.
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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.
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Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled.
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Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled.
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Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided.
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Subjects who had used PD-1/PD-L1 or other antitumor immunotherapeutic agents prior to enrollment should be avoided.
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The following subjects should be avoided: pregnant or lactating women; those who have childbearing potential and unwilling or unable to use effective contraception measures.
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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.- IIT20220057C