NCT06441019

Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma

Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for 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 – 80 Years
• Healthy volunteers: Not accepted

Summary

In recent years, with the emergence of various new targeted and immunotherapy drugs, drug therapy for advanced Hepatocellular carcinoma has also seen continuous breakthroughs. The effective rate, progression free survival, and overall survival of advanced Hepatocellular carcinoma have all significantly improved. At present, internationally recognized first-line treatments available include atezolizumab+bevacizumab (T+A), lenvatinib, sorafenib, Durvalumab+tremelimumab, etc. However, the effective rate of first-line treatment has not exceeded 50%, and most patients face difficulties such as drug resistance or treatment failure. Second line treatment for Hepatocellular carcinoma still faces many difficulties and challenges. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2868 and Ramucirumab in second-line treatment of advanced HCC patients.

Conditions

• Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, Ramucirumab

Interventions

Type	Name	Description
DRUG	HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab	The patient will receive combined treatment with HAIC, TQB2868, and Ramucirumab. After enrollment, the patient will undergo routine hepatic artery angiography via femoral artery catheterization and placement of a hepatic artery catheter，they will then receive 150ml of 5% sodium bicarbonate + Oxaliplatin (85mg/m2) for 4-6 hours + Raltitrexed (2mg/m2) for 2-4 hours . This will be done every 3-4 weeks for at least 2 cycles. Systemic treatment will be administered every 21 days, with TQB2868 injection given on the first day of each cycle (1-7 days after HAIC). The fixed dose of TQB2868 will be 300mg, and Ramucirumab will be given at a dose of 500mg (initial intravenous infusion for 60 minutes, followed by 30 minutes if tolerated).

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-05-31
• Completion: 2026-05-31
• First posted: 2024-06-04
• Last updated: 2024-06-21

Locations

1 site across 1 country: China