Combining mFOLFIRINOX and radiotherapy for advanced pancreatic cancer with normal CA19-9 levels
mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy
This study is testing if combining a specific chemotherapy treatment with radiotherapy can help people with advanced pancreatic cancer who have normal CA19-9 levels and haven't responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06249321 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of mFOLFIRINOX combined with radiotherapy in patients with advanced pancreatic cancer who have normal CA19-9 levels and are resistant to chemotherapy. The research focuses on patients diagnosed with pancreatic adenocarcinoma, a condition known for its poor prognosis. The study aims to assess progression-free survival, objective response rate, and overall survival among participants. By targeting a specific subset of patients, the study seeks to determine if this combination therapy can improve outcomes for those who typically have limited treatment options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with advanced pancreatic adenocarcinoma and normal CA19-9 levels who have not responded to prior chemotherapy.
Not a fit: Patients with elevated CA19-9 levels or those who have not received chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced pancreatic cancer who have normal CA19-9 levels and are refractory to chemotherapy.
How similar studies have performed: Previous studies have indicated that patients with normal CA19-9 levels may respond better to combined chemotherapy and radiotherapy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 \> 35 U/mL. * The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. * Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. * Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results. * Renal insufficiency or dialysis * Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. * Patients who are allergic to oxaplatin or other chemotherapy drugs. * Patients who are unwilling or unable to comply with study procedures.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Guopei Luo, MD — Fudan University
- Study coordinator: Ying Yang, MD
- Email: yangying@fudanpci.org
- Phone: 86 64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.