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

NCT06801665 | Recruiting Phase 2

• 1 other identifier: [2024]YLJSA162
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate will be assessed by investigators.

  up to 24 months

Secondary Outcomes (14)

• Median Progression-Free Survival (mPFS)

  up to 24 months

• Median Overall Survival (mOS)

  up to 24 months

• 6-Months Progression-Free Survival Rate (6month-PFS)

  up to 6 months

• 12-Months Progression-Free Survival Rate (12month-PFS)

  up to 12 months

• 18-Months Progression-Free Survival Rate (18month-PFS)

  up to 18 months

Study Arms (1)

FMT+QL1706+Bevacizumab+XELOX

EXPERIMENTAL

Combination Product: FMT+QL1706+Bevacizumab+XELOX

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.

FMT+QL1706+Bevacizumab+XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmed advanced colon cancer with liver metastasis.
• Signed written informed consent.
• Have not received anti-tumor treatment.
• According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
• Patients of both sexes, aged ≥18 years and ≤75 years.
• ECOG PS 0-1;
• Expected survival time ≥ 3 months;
• Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements, as follows:
• \) Blood routine: ANC ≥ 1.5 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, HGB ≥100 g/L (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: TBIL ≤1.5 x ULN; ALT/AST ≤ 5 x ULN; ALP ≤5×ULN; 3) Renal function: Cr ≤1.5×ULN, or creatinine clearance ≥50 mL/min: Urine routine results showed urinary protein \< 2+; 4) Coagulation function: INR or PT ≤1.5 x ULN. 9.For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration.
• \. For women of childbearing potential (WOCBP): agreement to refrain from heterosexual intercourse or use contraception.
• \. For men: agreement to refrain from heterosexual intercourse or use a condom, and agreement to refrain from donating sperm.

You may not qualify if:

• Suffered from other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid carcinoma.
• Patients requiring elective surgery during the trial.
• Patients who cannot take oral drugs, or have conditions that the investigator determines to significantly affect gastrointestinal absorption, such as chronic diarrhea, intestinal obstruction, etc., and are not suitable for treatment.
• Patients during pregnancy (positive pregnancy test) or lactation.
• Central nervous system metastasis or meningeal metastasis.
• Uncontrollable bone metastasis, or patients at risk of fracture, requiring surgery, local radiation therapy.
• Patients with active infection requiring systemic anti-infection treatment.
• Patients with a history of immunodeficiency, including those who are positive for HIV antibody tests.
• Patients with known, active autoimmune diseases.
• Patients with uncontrolled active hepatitis B, patients with hepatitis C virus infection (HCV antibody positive).
• A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe arrhythmia, acute coronary syndrome within 6 months, congestive heart failure, aortic dissection, stroke, and T IA history.
• Severe bleeding events occur within half a year, or high bleeding risk factors such as active digestive tract ulcers and esophageal and gastric varices due to liver cirrhosis.
• Patients with diabetes who cannot be stably controlled by drugs (including insulin).
• Mental or language disorders that prevent communication with the patient;
• Patients participating in another clinical trial.

Sponsors & Collaborators

• Hua Jiang: lead

Study Sites (1)

The Second People's Hospital of Changzhou

Changzhou, China

RECRUITING

Central Study Contacts

Hua Jiang MD

CONTACT

+86-18015852711; czeyjh@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 30, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)