Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC

Korábbi kezelés

• Time between surgery and enrollment >12 weeks.
• Receive anti-tumor treatment before surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, local therapy, etc.
• Receive other anti-tumor treatments, such as chemotherapy, radiotherapy, or other research drugs, during postoperative adjuvant therapy.
• Severe infection within 4 weeks before enrollment.

Egyéb

• Patient diagnosed with Ampulla of Vater(AoV).
• The tumor was not completely removed, or the postoperative pathology indicated that it was not a biliary tract tumor.
• Participated in another interventional clinical study.
• Other factors deemed by the investigator to make the participant unsuitable for participation in this study.

• Age ≥ 18 years, both males and females are eligible.
• Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).
• TNM stage before surgery: GBC/DCC T2-T4, N+, M0; ICC T1b-T4, N+, M0; PCC, any T, any N, M0 (according to UICC/AJCC TNM staging (8th edition)) .
• Patients must undergo radical resection, including liver resection or pancreatectomy, before enrollment.
• Time between surgery and enrollment < 12 weeks.
• R0 resection.
• ECOG PS 0-1.
• No distant metastasis confirmed by MRI.
• Adequate organ and marrow function, as defined below. Haemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Serum bilirubin ≤ 1.0 × ULN ALT and AST ≤ 2.5 × ULN Calculated creatinine clearance > 50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance.