Spots Global Cancer Trial Database for Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

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Trial Identification

Brief Title: Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

Official Title: Prospective, Single-arm, Multicenter Phase II Study of Evaluation of the Efficacy and Safety of Pemigatinib Combined With PD-1 Inhibitor in First-line Treatment of Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

Study ID: NCT05913661

Conditions

Carcinoma

Intrahepatic Cholangiocarcinoma

Digestive System Neoplasms

PD-1 Inhibitor

First-line Treatment

Interventions

Pemigatinib

PD-1 Inhibitors

Study Description

Brief Summary: This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.

Detailed Description: The study will be divided into two phases. The first phase is the safety import phase, in which three subjects with intrahepatic cholangiocarcinoma will be enrolled to receive a Scheduled dose of pemigatinib for one course of treatment， If the initial three subjects didn't develop DLT during the 21-day observation period, the dose will be considered tolerable and the study will proceed to Part II, otherwise, the dose will be adjusted and the evaluation will continue according to the above criteria. A total of 30 subjects will be enrolled in Phase II of the study, and all screening-qualified subjects will receive pemigatinib combined with PD-1 inhibitor. pemigatinib and PD-1 inhibitors will be administered at established doses according to a regimen until progressive disease, intolerable toxicity, or informed consent form has been withdrawn. PD-1 inhibitors will be administered for a maximum of 24 months.