Recruiting nowPhase 2
What this trial is trying to do
After colorectal cancer has progressed on an oxaliplatin-based first treatment, the researchers are testing a second-line combination of 5-FU, levofolinic acid and liposomal irinotecan, with cetuximab or bevacizumab for some patients. Liposomal irinotecan packages the irinotecan drug in fatty particles to alter how it is delivered; the trial asks whether this approach can control the cancer and remain tolerable.
The researchers hope this regimen will keep the cancer from growing for longer after first-line treatment, measured mainly by median progression-free survival (mPFS), while also assessing safety. Because the study has no comparison group, it cannot show that the combination is better than another second-line treatment.
Worth knowing: This is a small, single-centre, non-randomised study of about 30 people, and its main outcome is time before progression rather than overall survival.
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 | NCT07559760 |
|---|---|
| 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 | The First Hospital of Jilin University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
What it is measuring
mPFS
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
This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Not yet treated
- Already 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. Male or female, aged 18-75 years.
2. Histologically or cytologically confirmed colorectal adenocarcinoma.
3. Unresectable, MSS-type metastatic colorectal cancer that has failed or is intolerant to first-line standard oxaliplatin plus fluoropyrimidine ± targeted therapy.
- Failure definition: progression during or within 3 months after completing first-line oxaliplatin/fluoropyrimidine ± targeted therapy.
- Adjuvant setting: progression/recurrence during or within 6 months of completing adjuvant oxaliplatin-based chemotherapy/chemoradiation counts as first-line failure.
4. At least one measurable lesion by RECIST 1.1.
5. ECOG performance status 0-1.
6. Expected survival ≥ 3 months.
7. Adequate organ function within 14 days before enrollment (no transfusion or growth-factor support):
- Hematology: Hb ≥ 90 g/L; WBC ≥ 3.0 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; PLT ≥ 90 × 10⁹/L.
- Coagulation: INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN (stable anticoagulation at therapeutic range allowed).
- Renal: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
- Hepatic:
- No liver mets: TBIL ≤ 1.5 × ULN, ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN.
- Liver mets: TBIL ≤ 2 × ULN, ALT ≤ 5 × ULN, AST ≤ 5 × ULN.
- Cardiac: LVEF ≥ 50 %.
8. Voluntary written informed consent; willing and able to comply with study procedures and follow-up.
9.
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 NCT07559760, registered by The First Hospital of Jilin University 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.