Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Prospective, Single-arm, Phase II Trial.
In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma
• The patient must be required to sign an informed consent form;
• Age 18-75 years old, male or female;
• Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
• Child-Pugh score A;
• Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions;
• Advanced and unresectable ICC patients;
• The expected survival is longer than 12 weeks;
• At least 1 measurable liver lesion or non-liver lesion (according to RECIST 1.1);
• Functional indicators of vital organs meet the following requirements a Neutrophils ≥1.5\*109/L; platelets≥100\*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; b Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal value(ULN), T3, T4 are in the normal range; c bilirubin ≤ 2 times ULN; Alanine aminotransferase （ALT） and Aspartate aminotransferase （AST） ≤ 2 times ULN; serum creatinine ≤ 1.5 ULN, creatinine clearance rate ≥ 60ml / min;
⁃ Non-lactating or pregnant women, contraception during or after 3 months of treatment.