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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≥18 and ≤75 years old

• Histologically confirmed colorectal adenocarcinoma

• Radiological and/or pathological confirmation of liver metastases, with ≤5 lesions

• Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS

• Absence of extrahepatic metastases confirmed by CT, MRI, or PET/CT (if necessary)

• Primary colorectal tumor has been or can be radically resected

• Liver metastatic lesions are resectable (including radiofrequency ablation and SBRT), and postoperative NED (no evidence of disease) is expected. Resectable liver metastases are specifically defined as ① ≤5 metastatic lesions; ② R0 resection can be performed (including radiofrequency ablation and SBRT); ③ Sufficient residual liver volume is expected after resection; ④ At least one hepatic vein can be preserved after resection, with preserved blood flow in and out of the residual liver and preserved bile ducts, and can preserve at least two adjacent liver segments; ⑤ No extrahepatic metastases.

• No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions

• Normal hematological function (platelets \>90×109/L; white blood cells \>3×109/L; neutrophils \>1.5×109/L)

• Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 ULN, no ascites, normal coagulation function, albumin ≥35g/L

• Liver function classified as Child-Pugh grade A

• Serum creatinine below the upper limit of normal (ULN), or calculated creatinine clearance rate \>50ml/min (using Cockcroft-Gault formula)

• ECOG performance status 0-1

• Expected lifespan \>3 months

• Signed written informed consent

• Willing and able to be followed up until death or end of study or study termination.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yuhong Li, PhD
liyh@sysucc.org.cn
87342487
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 156
Treatments
Active_comparator: FOLFOX only group
Oxaliplatin: 85 mg/m2 IV on day 1 Fluorouracil (FU): 400 mg/m2 IV bolus on day 1, followed by 2.4 g/m2 continuous IV infusion over 48 hours Leucovorin: 200 mg/m2 IV on day 1 This treatment regimen is repeated every two weeks for a total of 6 cycles.
Experimental: Serplulimab + Bevacizumab + FOLFOX
Serplulimab: 200 mg IV infusion on day 1 Bevacizumab: 5 mg/kg IV infusion on day 1 Oxaliplatin, FU, and Leucovorin as per the control arm The experimental arm follows the same treatment schedule as the standard FOLFOX regimen, with the addition of Serplulimab and Bevacizumab for the first 3 cycles only.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials