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

Enrolled participants should be treated with neoadjuvant camrelizumab and apatinib and GEMOX, after surgery, be treated with adjuvant camrelizumab and S-1.

Inclusion criteria

• Informed consent document must be signed.
• Aged 18-75 years old, both genders.
• Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before.
• An Eastern Cooperative Oncology Group performance status of 0 to 1.
• Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion.
• 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.

• At least 1 measurable lesion as defined by RECIST 1.1.
• Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication.
• Subjects should have good compliance and cooperate with the follow-up.

Exclusion criteria

• 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.
• Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled.
• 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.
• 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.
• 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.
• Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled.
• Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled.
• Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided.
• Subjects who had used PD-1/PD-L1 or other antitumor immunotherapeutic agents prior to enrollment should be avoided.
• The following subjects should be avoided: pregnant or lactating women; those who have childbearing potential and unwilling or unable to use effective contraception measures.
• Other circumstances that could affect the trial or the result of the study judged by the investigator.