Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether adding fruquintinib, a drug that blocks signals helping tumour blood vessels grow, to FOLFIRI chemotherapy can control metastatic colorectal cancer after first-line treatment. They will also assess the combination’s safety.
The idea is that the two treatments may keep the cancer from growing for longer than chemotherapy alone, but this trial has no comparison group. Its main measure of possible benefit is the proportion of participants whose cancer has not progressed at six months, rather than how long they live overall.
Worth knowing: This is an open-label, single-arm phase 2 trial, so it cannot show from its design whether the combination is better than another treatment.
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 | NCT07011576 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 60 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | SCRI Development Innovations, LLC |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug fruquintinib
- Drug FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
What it is measuring
Progression-Free Survival (PFS) rate at 6 months
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 an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
* Evaluate the safety of the combination of fruquintinib + FOLFIRIWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
- Colon
- 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
Key Inclusion Criteria
- Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
- Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
- Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
Key Exclusion Criteria
- Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
- Major surgery within 4 weeks of the first planned dose of study treatment
- More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
- Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
- Uncontrolled, symptomatic brain metastases
- Uncontrolled, symptomatic gastrointestinal disease
- Participants with uncontrolled hypertension
- Wome…
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 14 sites. Listed in: United States.
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 NCT07011576, registered by SCRI Development Innovations, LLC 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.