NCT07105748

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a single arm, phase II study to determine the efficacy and safety of Camrelizumab plus rivoceranib combined with hepatic arterial infusion chemotherapy (HAIC) in patients with advanced mixed hepatocellular-cholangiocarcinoma (HCC-CCA).

Conditions

• Mixed Hepatocellular-cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab will be administered by IV, 200 mg every 2 weeks.
DRUG	Rivoceranib (Apatinib)	Rivoceranib will be administered by oral 250 mg once daily.
PROCEDURE	HAIC	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.

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-08-06
• Last updated: 2025-08-17

Locations

1 site across 1 country: China