Early multi-gene sequencing to guide therapy in advanced poor-prognosis cancers
Official title: Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers, Not Eligible for Initial Sequencing in Clinical Routine and Selected From the First Line in Molecular Tumour Board.
Run by University Hospital, Lille · NCT06958224 · Data updated 2026-11-12
This trial tests whether doing broad multigene sequencing early, with tumor-board input, can help choose targeted treatments for adults with advanced pancreatic, liver, or triple-negative breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | April 29, 2026 |
| Main results expected | November 10, 2028 |
| Study ends | January 9, 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06958224 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with unresectable or metastatic pancreatic adenocarcinoma, hepatocellular carcinoma, or triple-negative breast cancer who have adequate tissue available for sequencing and are fit for a targeted treatment proposal.
✕Probably not a fit
Patients without actionable targets or who do not respond to proposed targeted therapies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with unresectable or metastatic pancreatic cancer, liver cancer, or triple-negative breast cancer will be randomized to receive either early large-panel sequencing (including DNA and RNA panels) to guide therapy versus a standard-sequence approach after first-line treatment starts. The study uses molecular tumor board recommendations based on actionable targets (ESCAT II/IV) to decide on possible treatments. It includes evaluation of tumor mutational burden and MMR status, with tissue obtained from a visceral site or surgical sample. If needed, a repeat biopsy may be proposed in Part 2 of the study. The overall aim is to see if early comprehensive sequencing can improve access to targeted therapies and accelerate clinical research in poor-prognosis cancers.
Why it matters
Potential benefit: If successful, patients could receive more effective, personalized therapies sooner based on their tumor’s molecular profile.
How similar studies have gone: Prior work supports using molecular profiling to guide targeted therapies in cancer, but early large-gene sequencing with upfront treatment decisions is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* \- Age \>18 years.
* Advanced disease status ("unresectable" or "metastatic").
* Patient included either at the time of diagnostic investigation or during first line of treatment.
* Good general conditions, still compatible with a therapeutic proposal, WHO 0-1.
* The following tumour sites, with poor prognosis and for which ESCAT II/IV treatment targets can be found according to ESMO:
* pancreatic adenocarcinoma
* hepatocellular carcinomas,
* triple negative breast cancer.
* Tumour tissue a priori available in sufficient quantity: at least one biopsy from a visceral metastatic site or surgical specimen (if available) for eligible cancers.
* Patient covered by a social sercurity scheme
Exclusion Criteria:
* \- General condition WHO \>1 and/or nutritional status not compatible with a therapeutic proposal
* Limiting systemic cardiovascular, renal, bronchopulmonary or endocrinological comorbidities with the initiation of a therapeutic proposal
* Active infection or active chronic disease (diabetes, liver dysfunction, immune disease) making the patient's condition incompatible with a therapeutic proposal.
* A priori unavailable, in insufficient quantity or of suboptimal quality tumour material.
* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent.
Where it's running
-
Hôpital Claude Huriez - Service Oncologie
Lille, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.