NCT04523662

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

Status unknown Phase 2 Last updated 21 August 2020

What this trial tests

Phase 2 trial testing Camrelizumab Apatinib Mesylas in Hepatocellular Carcinoma in 27 participants. Status unknown.

Timeline

30 August 2020

Primary endpoint
1 August 2022

1 August 2022

Quick facts

Lead sponsor	Beijing Tsinghua Chang Gung Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	30 August 2020
Primary completion	1 August 2022
Estimated completion	1 August 2022

Drugs / interventions tested

• Camrelizumab Apatinib Mesylas — full drug profile →

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Beijing Tsinghua Chang Gung Hospital

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
   Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697
2. Cell Trafficking at the Intersection of the Tumor-Immune Compartments.
   Du W, Nair P, Johnston A, Wu PH, et al · · 2022 · cited 31× · PMID 35385679 · DOI 10.1146/annurev-bioeng-110320-110749
3. Mechanisms and Clinical Trials of Hepatocellular Carcinoma Immunotherapy.
   Huang SL, Wang YM, Wang QY, Feng GG, et al · · 2021 · cited 24× · PMID 34306031 · DOI 10.3389/fgene.2021.691391
4. Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: An Overview.
   van Doorn DJ, Takkenberg RB, Klümpen HJ. · · 2020 · cited 18× · PMID 33374927 · DOI 10.3390/ph14010003
5. The role of stereotactic body radiotherapy in hepatocellular carcinoma: guidelines and evidences.
   Hu Y, Zhao C, Ji R, Chen W, et al · · 2022 · cited 10× · PMID 39036452 · DOI 10.1016/j.jncc.2022.05.002