RecruitingPhase 2NCT06801665

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


Sponsor

Hua Jiang

Enrollment

30 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding fecal microbiome transplant (FMT) — transferring healthy gut bacteria from a donor — to standard first-line treatment (immunotherapy plus chemotherapy) improves outcomes for patients with advanced colon cancer that has spread to the liver and does not have a genetic mutation called MSS-type. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced colon cancer with liver metastases - You have not yet received any cancer treatment - You are in good performance status (ECOG 0–1) - You have at least one measurable tumor - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have previously received treatment for colon cancer - You have autoimmune disease or connective tissue disease - You are pregnant or breastfeeding - You have serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTFMT+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.


Locations(1)

The Second People's Hospital of Changzhou

Changzhou, China

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NCT06801665


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