Study on the Effectiveness and Safety of Carrelizumab Combined With Apatinib Mesylate and Radiotherapy in the Treatment of Advanced Liver Cancer

Sponsor
Beijing Tsinghua Chang Gung Hospital
Study ID
NCT04523662
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab Apatinib Mesylas — DRUG
    This study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis

Study Details

Literature has shown that radiotherapy can promote tumor antigen presentation, mobilize and activate T cells by enhancing activation signals and blocking inhibitory signals. It can also lead to the normalization of blood vessels in the tumor microenvironment and the increase of CXCL16 and other chemokines to activate T cells. The cells infiltrate the tumor tissues better and promote the killing activity of T cells. Therefore, the combined application of radiotherapy and immunotherapy may have a synergistic effect. Apatinib is a small molecule tyrosine protein kinase inhibitor for VEGFR. Low-dose apatinib can induce the normalization of abnormal blood vessels in tumors, effectively increase the infiltration of lymphocytes in tumor tissues, and block immunosuppressive myeloid cells. Recruitment, reverse the immunosuppressive state, effectively reduce the level of TGF-β, and make the tumor environment tend to have an immune support phenotype. Apatinib combined with PD-1 antibody karelizumab has been confirmed in a phase I study to have good efficacy and safety in patients with advanced liver cancer. Therefore, this study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis, to evaluate the effectiveness and safety of the combined therapy, and to provide new clinical treatments for liver cancer Evidence-based medicine.

Key Dates

Start date
Aug 30, 2020
Status verified
Aug 2020
Primary completion
Aug 1, 2022
Completion
Aug 1, 2022

Study Design

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

Arms

  • Experimental: Carrelizumab treatment group started during radiotherapy
  • Experimental: Start the carrelizumab treatment group within 3 days after the

Primary Outcome Measure

PFS [ Time Frame: 24months ]

Central Contacts

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