NCT06550453

Safety and Efficacy of Pembrolizumab in Combination with Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer

Recruiting now Phase 4 Last updated 12 November 2024

What this trial tests

Phase 4 trial testing Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) in Locally Advanced Colorectal Cancer in 20 participants. Currently enrolling.

Timeline

1 September 2024

Primary endpoint
15 January 2025

15 January 2026

Quick facts

Lead sponsor	yangjianjun
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 September 2024
Primary completion	15 January 2025
Estimated completion	15 January 2026
Sites	1 location across China

Drugs / interventions tested

• Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine) — full drug profile →

Conditions studied

• Locally Advanced Colorectal Cancer — all drugs for Locally Advanced Colorectal Cancer →

Sponsor

yangjianjun — full company profile →

Who can join

18 and older, any sex, with Locally Advanced Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer.

Methods and analysis: A prospective, open-label, single-arm, phase 2 clinical study protocol will enroll a total of 20 patients. The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer (LACRC) patients. Initially, 9 patients will be recruited in the Simon I phase, and if more than 1 patient achieves a pathological complete response (pCR), the study will proceed to the II phase. Recruit up to 20 patients in Phase II, and if more than 4 patients achieve pCR, the trial will be considered successful. All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine). The primary efficacy endpoint is the pathological complete response (pCR) of the cancer following neoadjuvant therapy. Secondary efficacy endpoints include major pathological response (MPR), objective response rate (ORR), and assessment of adverse events (AEs).

Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital (Xijing Hospital)(KY20232402-F-1)

Publications & conference data

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

1. Emerging strategies in colorectal cancer immunotherapy: enhancing efficacy and survival.
   Zhang Y, Guan H, Feng X, Liu M, et al · · 2025 · cited 1× · PMID 41112277 · DOI 10.3389/fimmu.2025.1616414
2. Role of neoadjuvant therapies in locally advanced colon cancer.
   Castria TB, Lenz G, Valagni G, Kim RD. · · 2025 · cited 1× · PMID 40736234 · DOI 10.1097/cm9.0000000000003756