NCT05111366

TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection

An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of TQB2450 Plus Anlotinib as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Resection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Xianhai Mao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is An Open, Single Arm, Multicenter, Exploratory Phase II study, to evaluate the efficacy and safety of TQB2450 Plus anlotinib as adjuvant therapy in hepatocellular carcinoma(HCC) patients at high risk of recurrence after resection. The patients who are confirmed by Histology or cytology as HCC with high-risk recurrence after R0 liver resection will be enrolled. 18 cycles adjuvant treatment with TQB2450 Plus anlotinib can improve one-year recurrence free survival (RFS) rate of HCC patients after R0 surgical resection.

Detailed description

TQB-2450 is a humanized mAb of PD-L1 that prevents PD-L1 from binding to PD-1 and B7.1 receptors on the T cell surface, 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

• Hepatocellular Carcinoma
• Adjuvant Therapy

Interventions

Type	Name	Description
DRUG	TQB2450 injection	TQB2450 is an injection in the form of 1200mg, ivgtt, q3W.
DRUG	Anlotinib hydrochloride capsules	Anlotinib Hydrochloride is a capsule in the form of 8 mg,10 mg, and 12 mg, orally, once daily, 2 weeks on/1 week off.

Timeline

• Start date: 2022-01-06
• Primary completion: 2024-01-20
• Completion: 2024-05-20
• First posted: 2021-11-08
• Last updated: 2022-05-04

Locations

1 site across 1 country: China