NCT06335147

PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer

PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer，Single Arm, Multicenter Phase II Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations

Detailed description

In this study, patients with advanced resectable metastatic colon cancer requiring neoadjuvant chemotherapy were selected, and colon cancer patients enriched with TNFSF10+CXCL10+ panTAMs subgroup were screened, and neoadjuvant chemotherapy was performed with PD-1 monoclonal antibody combined with chemotherapy. To evaluate the efficacy and safety of PD-1 monoclonal antibody combined with neoadjuvant chemotherapy in the treatment of special types of colon cancer. All patients in this study were examined in the tumor microenvironment before treatment, and only patients enriched with TNFSF10+CXCL10+ panTAMs subgroup were enrolled in the study. Due to the long detection time, the patient received mFOLFOX6 chemotherapy for one week in the first cycle. If the test results meet the enriched proinflammatory panmacrophage subpopulation, patients can eventually be enrolled and receive PD-1 monoclonal antibody (Serplulimab, Srulimab) combined with mFOLFOX6 (oxaliplatin, fluorouracil) regimen, 2 weeks for 1 cycle. The primary radical resection was performed after 5 cycles of neoadjuvant therapy. Local treatment of liver/lung metastases was performed at the same time or at different times. Continue mFOLFOX6 chemotherapy for 4-6 cycles or CAPEOX regimen for 4 cycles within 1-2 months after surgery. Liver and lung metastases allow local treatment in any of these treatment cycles, including but not limited to radiofrequency ablation, particle implantation, radiation therapy, and surgery. At the end of postoperative adjuvant therapy, NED status was achieved. Then, regular follow-up.

Conditions

• Metastatic Colon Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab, mFOLFOX6	Serplulimab，200mg，iv，q2w，d1； mFOLFOX6（Oxaliplatin: 85 mg/m2，LV ：400mg/m2，Fluorouracil： 400mg/m2 d1，2400 mg/m2 continuous intravenous drip for 46-48 hours；q2w）

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2024-03-28
• Last updated: 2024-03-28