NCT06801665

FMT+ QL1706+Bevacizumab+ XELOX as First-line Treatment for Advanced MSS-type Colon Cancer With Liver Metastasis

Fecal Microbiota Transplantation Combined With QL1706, Bevacizumab, and XELOX as First-line Treatment for Advanced MSS-type Colon Cancer With Liver Metastasis: A Prospective, Multi-center, Single-arm Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hua Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colon cancer patients with liver metastasis who have not received prior treatment. This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with QL1706+Bevacizumab+XELOX to enhance the anti-tumor immune effect at the same time, thereby improving the prognosis of colon cancer patients with liver metastasis.

Detailed description

This is a prospective, single-arm, multi-center, exploratory clinical study. Patients with previously untreated, newly diagnosed advanced colon cancer with liver metastasis, who could be diagnosed by histological or cytological means, ECOG PS 0-1, excluded Ras, Raf wild type left colon and rectum, excluded dMMR/MSI-H. Eligible subjects who met the inclusion criteria were screened and signed informed consent. FMT was performed 2 days before treatment with QL1706, bevacizumab, and chemotherapy. QL1706， bevacizumab, and chemotherapy (XELOX) were administered every 3 weeks according to the patient's body surface area. A total of 6 cycles were performed. Subsequent maintenance therapy was at the discretion of the investigator. RECIST v1.1 was used for tumor evaluation every 6 weeks during treatment. NCI-CTCAE 5.0 was used for safety assessment every 3 weeks. Adverse events were recorded throughout the study to 90 days after the end of treatment. Treatment continues until disease progression, subject withdraws informed consent, loss of follow-up, or death. Patients should provide 10ml whole blood samples and fecal samples at baseline, after two cycles of treatment, after four cycles of treatment, before maintenance treatment for the detection of efficacy prediction markers (each cycle is 21 days).

Conditions

• Colon Cancer Liver Metastases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	FMT+QL1706+Bevacizumab+XELOX	Participants will receive FMT combined with QL1706+Bevacizumab+XELOX for 6 cycles. If there is no progression of the disease after 6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. The therapy of maintenance treatment stage was at the discretion of the investigator.

Timeline

• Start date: 2025-04-17
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-01-30
• Last updated: 2026-01-02

Locations

1 site across 1 country: China