NCT06280495

Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients

Neoadjuvant Combination of Serplulimab and Bevacizumab With FOLFOX Versus FOLFOX Alone for Resectable Liver Metastases in RAS/BRAF Wild-Type, pMMR/MSS Colorectal Cancer Patients

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.

Detailed description

In this prospective, multi-center clinical trial titled "INTENSIFY," we seek to evaluate the potential benefits of integrating Serplulimab and Bevacizumab with the standard FOLFOX chemotherapy regimen as neoadjuvant treatment for surgically resectable colorectal cancer liver metastases (CRLM). Colorectal cancer remains a leading cause of global cancer-related morbidity and mortality, with liver metastases accounting for a significant proportion. Our primary objective is to investigate whether the addition of Serplulimab, a PD-1 inhibitor, and Bevacizumab, an anti-angiogenesis agent, can improve the postoperative prognosis for patients with RAS/BRAF wild-type, pMMR/MSS CRLM. We aim to address critical questions regarding the efficacy of this combined treatment in enhancing the immune microenvironment within the liver, ultimately leading to increased T lymphocyte infiltration and improved patient outcomes. The study will involve a randomized assignment of patients to either the standard FOLFOX chemotherapy arm or the experimental arm receiving FOLFOX in combination with Serplulimab and Bevacizumab. Participants will undergo neoadjuvant treatment, surgical resection, and regular follow-up assessments to evaluate treatment response, recurrence rates, and overall survival. By comparing outcomes between the two groups, specifically assessing factors like recurrence-free survival, overall survival, and changes in the immune microenvironment, we aim to provide valuable insights into the optimization of treatment strategies for this specific subset of colorectal cancer patients.

Conditions

• Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Oxaliplatin	5 mg/m2 IV on day 1
DRUG	Fluorouracil	400 mg/m2 IV bolus on day 1, followed by 2.4 g/m2 continuous IV infusion over 48 hours
DRUG	Serplulimab	200 mg IV infusion on day 1
DRUG	Bevacizumab	5 mg/kg IV infusion on day 1

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-02-28
• Last updated: 2025-05-30

Locations

1 site across 1 country: China