Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcrip… (NCT05475366) | Clinical Trial Compass
RecruitingNot Applicable
Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures
France85 participantsStarted 2022-12-12
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Measurable or evaluable lesions according to RECIST v1.1 criteria.
✓. First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed).
✓. Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14).
✓. 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
Exclusion criteria
✕. 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).
✕. Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (known positive Hepatitis B Virus surface antigen (HBsAg) result), hepatitis C (with positive RNA), Sars-Cov-2 or human immunodeficiency virus (positive HIV 1/2 antibodies).
What they're measuring
1
Objective Response Rate (ORR) at 4 months based on thorax-abdomen-pelvis (TAP) CT scan every 8 weeks according to RECIST v1.1.
✕. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
✕. Known active central nervous system metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline).
✕. Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure or coronary disease, peripheral artery disease, severe chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.