Phase 2 Study of ICP-192 for Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma Who Have Failed Prior Treatment

What this Trial Is About

Researchers are evaluating ICP-192, an oral drug, in a phase 2 clinical trial for patients with FGFR2-rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who have not responded to prior therapies. This single-arm, open-label, multi-center study aims to assess the drugs effectiveness and safety in this specific patient group. The study is sponsored by Beijing InnoCare Pharma Tech Co., Ltd. and focuses on a serious form of liver cancer that has progressed after chemotherapy. Participants will receive ICP-192 as a 5 mg oral tablet. The study does not include a comparison group and involves administration of the drug over a period of up to three years. It includes continuous monitoring of treatment effects and safety throughout this time. The trial evaluates not only the tumor response but also various pharmacokinetic measures such as maximum concentration and half-life of the drug in the body. During the study, patients will undergo regular assessments including imaging to measure tumor size and progression, laboratory tests to monitor organ function and drug levels, and evaluation of any side effects using standardized criteria. The primary outcome is the objective response rate over up to three years, with secondary outcomes including survival, disease control, and duration of response. Safety will be closely observed, and the total participation could last up to three years depending on the patients response and tolerance to the treatment.

A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma