NCT05438108

SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in First-line Treatment of mCRC

Status unknown Phase 2 Last updated 29 June 2022

What this trial tests

Phase 2 trial testing SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in Metastatic Colorectal Cancer in 30 participants. Status unknown.

Timeline

1 July 2022

Primary endpoint
31 January 2023

31 January 2024

Quick facts

Lead sponsor	Huazhong University of Science and Technology
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 July 2022
Primary completion	31 January 2023
Estimated completion	31 January 2024
Sites	1 location across China

Drugs / interventions tested

• SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Huazhong University of Science and Technology

Who can join

Adults 18 to 75, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immune checkpoint inhibitors have a poor effect on MSS colorectal cancer. Studies have shown that SBRT, chemotherapy and anti-vascular therapy can enhance the anti-tumor effect of PD-1 antibody. This is a prospective, single-arm study to explore the efficacy and safety of SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab in treatment with patients with initially unresectable advanced colorectal cancer.

Publications & conference data

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

1. The Interplay between Anti-Angiogenics and Immunotherapy in Colorectal Cancer.
   Maiorano BA, Parisi A, Maiello E, Ciardiello D. · · 2022 · cited 7× · PMID 36294987 · DOI 10.3390/life12101552
2. Immunotherapy combined with local therapy in the late-line treatment of repair-proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer.
   Ding Y, Weng S, Zhu N, Mi M, et al · · 2023 · cited 2× · PMID 38058653 · DOI 10.1016/j.heliyon.2023.e22092