Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers

Launched by UNIVERSITY HOSPITAL, LILLE · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how early testing of multiple genes in certain advanced cancers can help doctors find better treatment options. The trial focuses on three types of cancers that are often hard to treat: pancreatic cancer, liver cancer, and triple-negative breast cancer. Researchers want to see if doing a detailed gene test early in treatment can lead to more effective therapies compared to waiting until later stages. Participants will be randomly assigned to one of two groups: one will receive early gene sequencing right at the start of their treatment, while the other will have it done later.

To be eligible for this trial, participants must be over 18 years old and have advanced cancer that is not treatable with surgery. They should be in good overall health, as defined by specific criteria, and have enough tumor tissue available for testing. It's important for potential participants to know that they will need to provide consent to join the study and must be covered by a health insurance plan. This trial is currently not recruiting participants but aims to offer new insights into how to better treat these challenging cancers.

Gender

ALL

Eligibility 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.