RecruitingPhase 2NCT06335927

HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC

Hepatic Arterial Infusion Chemotherapy Combined With Cadonilimab and Regorafenib as Second-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma: a Single-arm, Phase II Study


Sponsor

Fudan University

Enrollment

45 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — HAIC (chemotherapy delivered directly into the liver), cadonilimab (a dual immune checkpoint blocker), and regorafenib (an oral targeted drug) — as a second-line treatment for bile duct cancer inside the liver (intrahepatic cholangiocarcinoma) that has stopped responding to standard first-line therapies. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with unresectable intrahepatic cholangiocarcinoma confirmed by biopsy - Your cancer has progressed on or you could not tolerate standard first-line chemotherapy - You have good functional status (ECOG 0–1) and expected survival of at least 3 months - Your liver function is adequate **You may NOT be eligible if...** - You have not tried any prior treatment for this cancer - You have had more than one prior line of systemic therapy - You have significant other organ disease or poor performance status - You have an active severe infection or autoimmune condition 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

DRUGHAIC-GEMOX+Cadonilimab+Regorafenib

HAIC-GEMOX: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles in combination with Cadonilimab (6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W)


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06335927


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