Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma
Trial Parameters
Brief Summary
This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.
Eligibility Criteria
Inclusion Criteria: * 1.Age range from 18 to 80 years old, regardless of gender; * 2.Histologically confirmed, unresectable advanced or metastatic BTC including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma. * 3\. Patients who have not received systematic treatment for BTC in the past . * 4.At least one measurable lesion (according to RECIST v1.1 requirements). * 5.ECOG PS: 0-1 points; * 6.Expected survival time ≥ 12 weeks; * 7\. The main organs are functioning normally and meet the following requirements White blood cell count ≥ 3.0× 10 9/L; Hb ≥ 90 g/l; Absolute neutrophil count ≥ 1.5× 10 9/L; Platelet count ≥ 100× 10 9/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 times the upper limit of normal limit (ULN); Total bilirubin ≤ 2 times of ≤ULN; Serum creatinine ≤ 1.5 times of ≤ULN; Albumin ≥ 30 g/l; * 8\. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days prior to enrol