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Colorectal Cancer Liver MetastasisPhase 2NCT06801665

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

A Phase 2 study testing FMT+QL1706+Bevacizumab+XELOX in people with Colorectal Cancer Liver Metastasis, run by Hua Jiang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Liver Metastasis
What is being tested?
FMT+QL1706+Bevacizumab+XELOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
17 Apr 2025to 1 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological confirmed advanced colorectal 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;
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  • 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:
  • 1) 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.
  • 10. For women of childbearing potential (WOCBP): agreement to refrain from heterosexual intercourse or use contraception.
  • 11. For men: agreement to refrain from heterosexual intercourse or use a condom, and agreement to refrain from donating sperm.

Who cannot join

  • 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.
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  • 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.
  • MSI-H/ d MMR without immunotherapy; left colorectum of Ras, Raf wild-type.
  • The investigator believes that the subject has other serious systemic diseases or other conditions that make him unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hua Jiang MD contact

+86-18015852711

czeyjh@njmu.edu.cn

China1 site, 1 recruiting

  • The Second People's Hospital of Changzhou

    Changzhou

    Hua Jiang MD, +86-18015852711

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

This is a prospective, single-arm, multi-center, exploratory clinical study. Patients with previously untreated, newly diagnosed advanced colorectal cancer with liver metastasis, who could be diagnosed by histological or cytological means, ECOG PS 0-1, excluded Ras, Raf wild type left colon/rectum, excluded dMMR/MSI-H. Eligible subjects who met the inclusion criteria were screened and signed informed consent.

FMT was performed 2 days after treatment with 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).

Being tested
FMT+QL1706+Bevacizumab+XELOX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMT+QL1706+Bevacizumab+XELOXCombination 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 groups in NCT06801665
Study groupRoleWhat they receive
FMT+QL1706+Bevacizumab+XELOXExperimentalNot described
Receives: Combination Product: FMT+QL1706+Bevacizumab+XELOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective response rate will be assessed by investigators.

    Measured: up to 24 months

Secondary outcomes (14)

  1. Median Progression-Free Survival (mPFS)

    Observation for mPFS will be recorded until the end of follow-up after the start of 1st cycle of treatment.

    Measured: up to 24 months

  2. Median Overall Survival (mOS)

    The time from the first treatment to death from any cause.

    Measured: up to 24 months

  3. 6-Months Progression-Free Survival Rate (6month-PFS)

    The proportion of patients whose disease did not progress 6 months after treatment

    Measured: up to 6 months

  4. 12-Months Progression-Free Survival Rate (12month-PFS)

    The proportion of patients whose disease did not progress 12 months after treatment

    Measured: up to 12 months

  5. 18-Months Progression-Free Survival Rate (18month-PFS)

    The proportion of patients whose disease did not progress 18 months after treatment

    Measured: up to 18 months

  6. 6-Months overall survival rate(6-Months-OS Rate)

    The proportion of patients who have not died after 6-Months of treatment

    Measured: up to 6 months

  7. 12-Months overall survival rate(12-Months-OS Rate)

    The proportion of patients whose disease did not progress 12 months after treatment

    Measured: up to 12 months

  8. 18-Months overall survival rate(18-Monthsr-OS Rate)

    The proportion of patients who have not died after 18 months of treatment

    Measured: up to 18 months

  9. Objective Response Rate (ORR) of liver metastases

    Objective response rate will be assessed by investigators.

    Measured: up to 24 months

  10. Disease Control Rate (DCR)

    The proportion of patients whose tumors achieve a response (CR+PR) and stable disease (SD) after treatment for the minimum duration required.

    Measured: up to 24 months

  11. Surgical conversion rate

    Proportion of inoperable patients converted to operable.

    Measured: up to 24 months

  12. Incidence of Adverse events (AEs)

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    Measured: up to 24 months

  13. Quality of Life (QoL)

    QoL(quality of life) will be evaluated by EORTC-QLQ-C30.The total score ranges from 0 to 60, with higher scores indicating better quality of life

    Measured: up to 24 months

  14. The Diversity of Fecal Microbiota

    This will be detected by 16s rRNA sequencing or metagenomes.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study start17 Apr 2025
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06801665
Sponsor's protocol ID
[2025]YLJSA057-01
Status last verified
Sep 2026
First submitted
25 Jan 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FMT+QL1706+Bevacizumab+XELOX in people with Colorectal Cancer Liver Metastasis, run by Hua Jiang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hua Jiang MD (+86-18015852711, czeyjh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06801665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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