NCT04547452

Combination of Sintilimab and Stereotactic Body Radiotherapy in Advanced Metastatic HCC

Status unknown Phase 2 Last updated 14 September 2020

What this trial tests

Phase 2 trial testing Stereotactic body radiation therapy in Stage IV HCC in 84 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
1 July 2022

1 July 2023

Quick facts

Lead sponsor	West China Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	1 July 2020
Primary completion	1 July 2022
Estimated completion	1 July 2023
Sites	1 location across China

Drugs / interventions tested

• Stereotactic body radiation therapy — full drug profile →
• Anti-PD-1 antibody drug named Sintilimab — full drug profile →

Conditions studied

• Stage IV HCC — all drugs for Stage IV HCC →
• Immunotherapy — all drugs for Immunotherapy →
• SBRT — all drugs for SBRT →

Sponsor

West China Hospital

Who can join

Adults 18 to 70, any sex, with Stage IV HCC or Immunotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is a common malignancy, and more than 70% of newly diagnosed HCC patients already have advanced disease. Sorafenib and lenvatinib are recommended as first-line options for advanced HCC. The PD-1 monoclonal antibody，such as nivolumab and pembrolizumab, have been approved to treat the patients with advanced HCC by the FDA. Combining radiotherapy with immune checkpoints showed promising response rates and improved survival in several solid tumor types. The purpose of this randomized study is to determine whether stereotactic body radiation therapy (SBRT) combined with sintilimab (an anti-PD-1 antibody) will improve the response to the anticancer treatment compared to sintilimab alone in patients with advanced HCC.

About 84 participants will be enrolled in this study. All will take part at West China Hospital, Sichuan University.

Publications & conference data

8 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. Advances in radiotherapy and immunity in hepatocellular carcinoma.
   Yang Y, Xiong L, Li M, Jiang P, et al · · 2023 · cited 37× · PMID 37542324 · DOI 10.1186/s12967-023-04386-y
3. The Current Role of Stereotactic Body Radiation Therapy (SBRT) in Hepatocellular Carcinoma (HCC).
   Kimura T, Fujiwara T, Kameoka T, Adachi Y, et al · · 2022 · cited 36× · PMID 36139545 · DOI 10.3390/cancers14184383
4. Optimizing the Treatment Schedule of Radiotherapy Combined With Anti-PD-1/PD-L1 Immunotherapy in Metastatic Cancers.
   Kong Y, Ma Y, Zhao X, Pan J, et al · · 2021 · cited 34× · PMID 33859942 · DOI 10.3389/fonc.2021.638873
5. Radiotherapy as an immune checkpoint blockade combination strategy for hepatocellular carcinoma.
   Lee BM, Seong J. · · 2021 · cited 19× · PMID 33776363 · DOI 10.3748/wjg.v27.i10.919
6. Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: An Overview.
   van Doorn DJ, Takkenberg RB, Klümpen HJ. · · 2020 · cited 18× · PMID 33374927 · DOI 10.3390/ph14010003
7. Stereotactic Body Radiation Therapy (SBRT) Plus Immune Checkpoint Inhibitors (ICI) in Hepatocellular Carcinoma and Cholangiocarcinoma.
   Jiang J, Diaz DA, Nuguru SP, Mittra A, et al · · 2022 · cited 15× · PMID 36612046 · DOI 10.3390/cancers15010050
8. Radiation and Immune Checkpoint Inhibitors: Combination Therapy for Treatment of Hepatocellular Carcinoma.
   Chami P, Diab Y, Khalil DN, Azhari H, et al · · 2023 · cited 13× · PMID 38069095 · DOI 10.3390/ijms242316773