Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitut Curie
About this trial
The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).
Metastatic disease.
Disqualifiers
Concurrent enrolment in another interventional clinical study.
Previous treatment with chemotherapy for pancreatic cancer.
Uncontrolled massive pleural effusion or massive ascites.
Known deficiency in UGT1A1 (homozygous UGT1A1*28 allele).
Trial design
Design model
Single group
Treatments tested in this trial
Clinical value of 5 transcriptomic signatures to personalize the therapeutic decision for L1 in PDAC
Other interventionFormalin-Fixed Paraffin-Embedded (FFPE) samples will be centralized in which nucleic acids extraction (DNA+RNA) and FFPE-compatible RNA-sequencing will be performed in real-time (≤28 days). RNAseq reads will be processed and all 5 transcriptomic signatures will be applied for prediction of response to 5FU, oxaliplatin, irinotecan, gemcitabine and taxane. In addition, biomarkers status will be obtained for all patients as part of good clinical practice.
Biomarkers of tumor signatures (translational studies)
Other interventionBlood (serum and plasma) will be drawn at baseline, week 8, and tumor progression in order to look for surrogate biomarkers of tumor signatures in liquid biopsy
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Molecular screening for prediction of responseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) at 4 months based on thorax-abdomen-pelvis (TAP) CT scan every 8 weeks according to RECIST v1.1.
ORR, defined as the percentage of patients whose disease decreased by at least 30% (partial response - PR) and/or disappeared (complete response - CR) under treatment among patients who start treatment.
Time frame
4 monthsSecondary outcomes
1
Progression-Free Survival (PFS)
PFS, defined as the time from the date of treatment initiation to the date of progression or death whatever the cause. Progression will be assessed by the investigator based on TAP-CT scan every 8 weeks according to RECIST v1.1.
Time frame
18 months2
Overall Survival (OS)
OS, defined from the date of treatment initiation to the date of death whatever the cause.
Time frame
18 months3
Disease Control Rate (DCR)
DCR, defined as the percentage of patients who have achieved complete response, partial response or stable disease according to RECIST v1.1 among patients who start treatment.
Time frame
18 months4
Treatment-related severe (grade 3-5) toxicities
Toxicities will be graded, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (digestive, hematologic, neuropathy).
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov