NCT05311319

HAIC Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients With High Risk of Recurrence After Resection

Hepatic Artery Infusion Chemotherapy(HAIC) Combined With Anlotinib and TQB2450 as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.

Detailed description

The high incidence of HCC recurrence following liver resection is a serious issue. However, no adjuvant therapy has been widely recognized at present. Interventional therapy and systemic drug therapy are common treatment methods and effective treatment for liver cancer. The combination of multiple drugs may reduce the recurrence in HCC patients with high-risk recurrence. TQB2450 is a humanized monoclonal antibody of programmed death-ligand1 (PD-L1), enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling.

Conditions

• Hepatocarcinoma

Interventions

Type	Name	Description
DRUG	HAIC+TQB2450+Anlotinib	HAIC: FOLFOX for 24hour perfusion chemotherapy. Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. TQB2450: 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.

Timeline

• Start date: 2022-01-11
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-04-05
• Last updated: 2022-04-05

Locations

1 site across 1 country: China