NCT06475287

HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma

The Efficacy and Safety of HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single Arm Exploratory Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. The overall situation is still unsatisfactory, with low objective tumor response rates and targeted immune resistance being the main reasons affecting treatment efficacy. Increasing local treatment or overcoming resistance is currently a hot research topic. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2450 and anlotinib for second-line treatment of advanced HCC patients.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	HAIC（Mitoxantrone+Raltitrexed）、anlotinib、TQB2450	The combination therapy of HAIC with TQB2450 and Anlotinib was administered to enrolled patients in no particular order. Patients received routine hepatic artery catheterization via femoral artery puncture, followed by routine hepatic artery catheterization and infusion chemotherapy with 5% sodium bicarbonate 150ml + liposomal mitoxantrone (10mg) for 2-4 hours + Raltitrexed (2mg/m2) for 2-4 hours, every three weeks for at least two cycles. Systemic treatment was given every 21 days, with a fixed dose of 1200mg of TQB2450 injection on the first day of each systemic treatment cycle (1-7 days after HAIC treatment), administered intravenously over 60 minutes initially, followed by 30 minutes if tolerated. Anlotinib was administered orally once daily at a dose of 10mg, with a two-week break every three weeks. Treatment continued until unacceptable toxicity or loss of clinical benefit (as assessed by the investigator based on imaging, biochemical indicators, and patient clinical status).

Timeline

• Start date: 2024-07-20
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: China