drugset / Trial / NCT05111366

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

NCT05111366

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-01-06
Primary completion
2024-01-20
Completion
2024-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Benmelstobart Monoclonal antibody 1200 mg Intravenous
Subject Catequentinib Small molecule 8 mg Oral
Subject Catequentinib Small molecule 10 mg Oral
Subject Catequentinib Small molecule 12 mg Oral