Spots Global Cancer Trial Database for HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC
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Trial Identification
Brief Title: HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC
Official Title: Hepatic Arterial Infusion Chemotherapy Combined With Cadonilimab and Regorafenib as Second-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma: a Single-arm, Phase II Study
Study ID: NCT06335927
Conditions
Interventions
Study Description
Brief Summary: This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma. The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
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