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Recruiting Phase 2 NCT06249321

mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy

Trial Parameters

Condition Pancreatic Cancer
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-04-01
Completion 2026-03-01
Interventions
mFOLFIRINOX plus IMRT

Brief Summary

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy.

Eligibility Criteria

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Age ≥ 18 years and ≤ 80 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Histologically or cytologically confirmed advanced pancreas adenocarcinoma. * Patients who are refractory to at least one line of chemotherapy and who have not received radiotherapy. * Locally advanced or distant metastatic pancreatic cancer. * Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL. * Presence of at least of one measurable lesion in agreement to RECIST criteria. * The expected survival ≥ 3 months. * Adequate organ performance based on laboratory blood tests. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: * Pregnant or nursing women. * Primary pancreatic cancer. * Baseline serum CA19-9 \> 37 U/mL, CEA \> 5.2 ng/mL, or CA125 \> 3

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