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RecruitingPhase 2NCT05678270

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

A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions/Rearrangements Who Have Failed Prior Therapy

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

70 participants

Start Date

Nov 15, 2022

Study Type

INTERVENTIONAL

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Summary

This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed prior therapy

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called ICP-192 for people with a specific type of bile duct cancer (intrahepatic cholangiocarcinoma) that has a particular genetic rearrangement in a gene called FGFR2. This cancer is located inside the liver and is unresectable or has spread. **You may be eligible if...** - You are at least 18 years old - You have confirmed intrahepatic cholangiocarcinoma (a liver bile duct cancer) that cannot be surgically removed or has spread - Your tumor has a specific genetic change called an FGFR2 fusion or rearrangement, confirmed by lab testing - Your cancer has progressed after at least one prior chemotherapy treatment - Your organs are functioning adequately **You may NOT be eligible if...** - You have previously been treated with a targeted FGFR inhibitor drug - You have active bleeding, uncontrolled infections, or uncontrolled high blood pressure - You have significant heart, liver, or kidney disease - You have active hepatitis B or C, or HIV - You are pregnant or breastfeeding - You have had recent major surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGICP-192

ICP-192 is a round, uncoated tablet, 5mg, orally.

Locations(44)

Anhui Provincial Hospital

Hefei, Anhui, China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Youan Hosptital,Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fujian, Fujian, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Mengchao hepatobiliary Hospital of FuJian Medical university

Fuzhou, Fujian, China

Foshan First People's Hospital

Foshan, Guangdong, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

First Affiliated Hospital of Zhengzhou University.

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Human Provincial People's Hospital

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Third Xiangya Hospital of Central South Uninversity

Changsha, Hunan, China

Changzhou Tumor Hospital

Changzhou, Jiangsu, China

Jiangyin Renmin Hospital

Jiangyin, Jiangsu, China

The Affiliated Hospital of Nanjing University Meidical School

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, China

Jiangxi Cancer Hospital

Nanchang, Nanchang, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Tangdu Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, China

Qilu Hospital

Jinan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

ZhongShan Hospital

Shanghai, Shanghai Municipality, China

The Third Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Shulan（Hangzhou） Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT05678270

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