NCT04030260

Regorafenib and PD-1 Antibody in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer

Status unknown Phase 2 Last updated 23 March 2023

What this trial tests

Phase 2 trial testing Regorafenib and PD-1 antibody in Combination with Radiotherapy in Colorectal Cancer Metastatic in 28 participants. Status unknown.

Timeline

19 July 2019

Primary endpoint
20 February 2023

19 July 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	19 July 2019
Primary completion	20 February 2023
Estimated completion	19 July 2023
Sites	1 location across China

Drugs / interventions tested

• Regorafenib and PD-1 antibody in Combination with Radiotherapy — full drug profile →
• Radiation therapy — full drug profile →

Conditions studied

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

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Colorectal Cancer Metastatic or MSS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months.

Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to explore the safety and efficacy of regorafenib and PD-1 antibody with or without radiotherapy in previously treated metastatic colorectal cancer patients with pMMR/MSS.

Publications & conference data

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

1. Immunotherapy in colorectal cancer: current achievements and future perspective.
   Fan A, Wang B, Wang X, Nie Y, et al · · 2021 · cited 321× · PMID 34671202 · DOI 10.7150/ijbs.64077
2. Immune Checkpoint Inhibitors in pMMR Metastatic Colorectal Cancer: A Tough Challenge.
   Marmorino F, Boccaccino A, Germani MM, Falcone A, et al · · 2020 · cited 39× · PMID 32824490 · DOI 10.3390/cancers12082317
3. Molecular subtypes and the evolution of treatment management in metastatic colorectal cancer.
   Martini G, Dienstmann R, Ros J, Baraibar I, et al · · 2020 · cited 36× · PMID 32782486 · DOI 10.1177/1758835920936089
4. The Efficacy of Immune Checkpoint Inhibitors in Microsatellite Stable Colorectal Cancer: A Systematic Review.
   Guven DC, Kavgaci G, Erul E, Syed MP, et al · · 2024 · cited 35× · PMID 38309719 · DOI 10.1093/oncolo/oyae013
5. Perspectives on Immunotherapy of Metastatic Colorectal Cancer.
   Dai Y, Zhao W, Yue L, Dai X, et al · · 2021 · cited 23× · PMID 34178645 · DOI 10.3389/fonc.2021.659964
6. Colon cancer and immunotherapy-can we go beyond microsatellite instability?
   Breakstone R. · · 2021 · cited 21× · PMID 33409406 · DOI 10.21037/tgh.2020.03.08
7. Overcoming physical stromal barriers to cancer immunotherapy.
   Chung SW, Xie Y, Suk JS. · · 2021 · cited 20× · PMID 34351575 · DOI 10.1007/s13346-021-01036-y
8. The characteristics of the tumor immune microenvironment in colorectal cancer with different MSI status and current therapeutic strategies.
   Wang Q, Yu M, Zhang S. · · 2024 · cited 19× · PMID 39877377 · DOI 10.3389/fimmu.2024.1440830