The Safety and Efficacy of Thermal Ablation Combined With Apatinib and Carilimub for Advanced Liver Cancer

Sponsor
Chinese PLA General Hospital
Study ID
NCT04204577
Phase
PHASE2
Status
Unknown

Conditions

  • BCLC Stage B Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate — DRUG
    Evaluation of the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for advanced liver cancer.

Study Details

The purpose of this study was to evaluate the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for the treatment of advanced liver cancer.

Key Dates

Start date
Nov 1, 2019
Status verified
Dec 2019
Primary completion
Nov 30, 2021
Completion
Nov 30, 2023

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Thermal ablation
    Taking standard thermal ablation treatment. Its specific number and time interval depend on the patient's own condition and disease.
  • Experimental: Thermal ablation combined with apatinib
    Taking standard thermal ablation treatment. Its specific number and time interval depend on the patient's own condition and disease. Oral apatinib mesylate tablets, 250 mg, orally once a day. Take about half an hour after a meal (the daily dose should be as much as possible), and take it with warm water. Apatinib was discontinued 7 days before each thermal ablation treatment, and after the thermal ablation treatment, the patient's aminotransferase returned to normal and continued to take apatinib.
  • Experimental: Ablation combined with apatinib and PD-1 antibody SHR-1210
    Taking standard thermal ablation treatment. Its specific number and time interval depend on the patient's own condition and disease. Oral apatinib mesylate tablets, 250 mg, orally once a day. Take it with warm water about half an hour after a meal (the daily dose should be as much as possible). Apatinib was discontinued 7 days before each thermal ablation treatment, and after the thermal ablation treatment, the patient's aminotransferase returned to normal and continued to take apatinib. SHR-1210, 200mg, intravenous infusion for 30 minutes (including the time of the tube,the overall infusion time is not shorter than 20 minutes, no longer than 60 minutes), once every 2 weeks; the first dose with the apatite Simultaneous administration of PD, PD-1 injection is not affected by thermal ablation.

Primary Outcome Measure

Progression-Free-Survival(PFS) [ Time Frame: Up to two years ]

Central Contacts