Recruiting nowPhase 2
What this trial is trying to do
The researchers think faecal microbiota transplantation (FMT), intended to alter the gut’s microbial community, could strengthen the anti-tumour immune effect of QL1706 when combined with bevacizumab and XELOX chemotherapy (capecitabine plus oxaliplatin). The trial is testing this combination as first treatment for advanced colorectal cancer that has spread to the liver.
The idea is that changing the gut microbiome alongside immune treatment, anti-blood-vessel treatment and chemotherapy might produce more tumour shrinkage than these treatments would otherwise achieve. The study will mainly measure objective response rate—the proportion of patients whose tumours shrink by a predefined amount—not how long patients live or how long treatment controls the cancer.
Worth knowing: This is a small, non-randomised phase 2 study with no comparison group, so any tumour responses cannot readily be separated from the effects of the individual treatments in the combination.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06801665 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 30 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Hua Jiang |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Combination product FMT+QL1706+Bevacizumab+XELOX
What it is measuring
Objective Response Rate (ORR)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Histological or cytological confirmed advanced colorectal cancer with liver metastasis.
2. Signed written informed consent.
3. Have not received anti-tumor treatment.
4. According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
5. Patients of both sexes, aged ≥18 years and ≤75 years.
6. ECOG PS 0-1;
7. Expected survival time ≥ 3 months;
8. 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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06801665, registered by Hua Jiang on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.