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

NCT04665362 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Advanced/Metastatic Hepatocellular Carcinoma

Interventions

DRUG

Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib

Drug: Recombinant oncolytic virus M1 Recombinant oncolytic virus M1 is administered intravenously 1×109 CCIC50 once daily on day1-5, every 28 day cyle. Other name：M1-c6v1 Drug：Anti-PD-1 antibody Anti-PD-1 antibody is administered intravenously 200 mg once every 2 weeks. Other names：SHR-1210, Camrelizumab Drug: Apatinib Apatinib is administered orally 250mg once daily. Other name: Apatinib

Sponsors & Collaborators

  • Guangzhou Virotech Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Liang Peng

    lead OTHER

Principal Investigators

  • Liang Peng, MD · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665362 on ClinicalTrials.gov