RecruitingPhase 2Phase 3NCT06280495

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


Sponsor

Sun Yat-sen University

Enrollment

156 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two approaches to treating colorectal cancer that has spread to the liver: standard chemotherapy (FOLFOX) alone versus FOLFOX combined with two additional drugs — serplulimab (an immunotherapy) and bevacizumab (a drug that blocks tumor blood vessel growth). The goal is to shrink tumors enough that they can be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have colorectal cancer that has spread only to the liver (up to 5 spots) with no spread elsewhere - Your tumor has been tested and is RAS wild-type, BRAF wild-type, and has a specific marker (pMMR/MSS) - Your primary colorectal tumor has been or can be removed with surgery - Your liver tumors are considered resectable (removable) or treatable with ablation - You have not had prior treatment for the liver metastases - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have cancer spread outside the liver - You have autoimmune conditions or prior serious immune-related side effects - You are pregnant or breastfeeding - You have active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin

5 mg/m2 IV on day 1

DRUGFluorouracil

400 mg/m2 IV bolus on day 1, followed by 2.4 g/m2 continuous IV infusion over 48 hours

DRUGSerplulimab

200 mg IV infusion on day 1

DRUGBevacizumab

5 mg/kg IV infusion on day 1


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06280495


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