Efficacy and Safety of Apatinib Combined With Adebrelimab and GEMOX Regimen Chemotherapy as the First-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (ICC): A Single-arm, Multicenter, Phase II Study
The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)
• 1\. Provided informed consent and sign the informed consent form;
• 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
• 3\. Histologically or cytologically confirmed ICC;
• 4\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
• 5\. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);
• 6\. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)
• 7\. Child-Pugh class: Grade A;
• 8\. ECOG-PS score: 0-1;
• 9\. With a life expectancy of ≥ 12 weeks;
• 10\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;
• 11\. If subjects have active hepatitis B (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be \< 500 IU/mL (or must be \< 2500 copy/mL if copy/mL is the only unit available in the study site) and are willing to receive antiviral therapy throughout the study (treatment in accordance with local standard of care, e.g., entecavir);
• 12\. Women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. A negative serum pregnancy test (HCG) must be confirmed within 7 days before starting study treatment. Lactating women are excluded;
• 13\. Men with female partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. Men must also agree not to donate sperm during this period. For men whose partners are pregnant, condom use is required without additional contraception;