Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Diagnosis of colorectal cancer with distant extrahepatic metastases
Prior chemotherapy, targeted therapy, intervention, or immunotherapy for liver metastases
No planned surgical resection for liver metastatic lesions
Received oxaliplatin-containing adjuvant chemotherapy regimen within the past one year
Trial design
Treatments tested in this trial
- Oxaliplatin
- Fluorouracil
- Serplulimab
- Bevacizumab
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov