drugset / Trial / NCT04665362

IIT Study of M1-c6v1 Combined With SHR-1210 and Apatinib in Patients With HCC

NCT04665362

NaSingle-groupOpen-labelTreatment

Summary

This is a single arm and open-label phase I trial to evaluate the safety, tolerability and efficacy of the oncolytic virus M1 (M1-c6v1)(iv 1×109 CCIC50, 1 dose per day, on day 1-5 each 28 day cycle) combined with anti-PD-1 antibody SHR-1201 (iv, 200 mg, once every two weeks) and Apatinib (po. 250 mg qd ) in the patients with advanced/metastatic hepatocellular carcinoma. 10 participants will be sequentially enrolled. The treatment duration is 12 months. All patients continue combination treatment until disease progression, unacceptable toxicity, death, or discontinuation for any reason.

Timeline

Start
2021-01-25
Primary completion
2022-06-01
Completion
2022-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject M1-c6v1 Unknown 1e+09 unknown Intravenous
Subject Rivoceranib Small molecule 250 mg Oral