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RECRUITING
NCT06280495
PHASE2/PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2024-02-01

Completion Date

2028-12-31

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China