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

Sponsor
Hua Jiang
Study ID
NCT06801665
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Liver Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FMT+QL1706+Bevacizumab+XELOX — COMBINATION_PRODUCT
    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.

Study Details

The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colorectal 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 colorectal cancer patients with liver metastasis.

Key Dates

First listed
Jan 30, 2025
Start date
Apr 17, 2025
Status verified
Sep 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FMT+QL1706+Bevacizumab+XELOX

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 24 months ]

Central Contacts