RecruitingPhase 2NCT07105748

HAIC Combined With Camrelizumab Plus Rivoceranib for Advanced Mixed Hepatocellular-cholangiocarcinoma (HCC-CCA)

HAIC Combined With Camrelizumab Plus Rivoceranib for Advanced Mixed Hepatocellular-cholangiocarcinoma (HCC-CCA) (TASK-05): a Single Arm, Phase 2 Study


Sponsor

Fudan University

Enrollment

45 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate HAIC combined with Camrelizumab plus rivoceranib for advanced mixed hepatocellular-cholangiocarcinoma (HCC-CCA).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment — HAIC (a way to deliver chemotherapy directly to the liver through an artery), camrelizumab (an immunotherapy drug), and rivoceranib (a targeted anti-tumor drug) — for people with a rare form of liver cancer called mixed hepatocellular-cholangiocarcinoma. **You may be eligible if...** - You are 18 or older - You have been diagnosed with mixed hepatocellular-cholangiocarcinoma (a liver cancer that has features of both main liver cancer types), confirmed by biopsy - Your cancer cannot be removed by surgery or treated with local therapies - You have not received prior systemic (whole-body) treatment for liver cancer - Your liver function is acceptable (Child-Pugh score 5–7) and overall health is good **You may NOT be eligible if...** - You have already received systemic cancer treatment for liver cancer - You have uncontrolled hepatitis B (viral load too high) - Your liver or blood function is too compromised - You have active autoimmune disease 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

DRUGCamrelizumab

Camrelizumab will be administered by IV, 200 mg every 2 weeks.

DRUGRivoceranib (Apatinib)

Rivoceranib will be administered by oral 250 mg once daily.

PROCEDUREHAIC

FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 4 weeks for up to 6 cycles. Camrelizumab plus rivoceranib will be administered 1-3 days after HAIC.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07105748