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.
1. Known hepatocellular carcinoma, Combined Hepatocellular and Intrahepatic Cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, fibrolamellar carcinoma of liver;
2. Other active malignant tumor except ICC within 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;
3. Planning to or previously received organ or allogenic bone marrow transplantation;
4. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
Single group
Apatinib and Adebrelimab in Combination With chemotherapy
DrugPatients would receive Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles. Apatinib and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
objective response rate (ORR)
the objective response rate (ORR) of advanced ICC patients who progressed after standard treatment with Adebrelimab and apatinib plus GEMOX.
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0
progression free survival (PFS)
PFS was defined as the time from the start of treatment to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or date of death, whichever occurred first.
overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or loss of follow-up
Click on the lead sponsor to view all of their trials.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
