Combining chemotherapy and radiotherapy for advanced pancreatic cancer with elevated CA19-9 levels
Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy
This study is testing if combining chemotherapy and radiation can help people with advanced pancreatic cancer and high CA19-9 levels live longer without their cancer getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (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 | NCT06250972 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining chemotherapy with radiotherapy in patients with advanced pancreatic adenocarcinoma who have elevated levels of the biomarker CA19-9 and are not resistant to chemotherapy. The trial aims to assess progression-free survival and overall response rates in this patient population. Participants will receive treatments including Gemcitabine, Nab-paclitaxel, and Irinotecan, along with Intensity-Modulated Radiation Therapy (IMRT). The study focuses on patients diagnosed with locally advanced pancreatic cancer and aims to provide insights into treatment efficacy based on CA19-9 levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with advanced pancreatic adenocarcinoma and elevated CA19-9 levels who have not previously received radiotherapy.
Not a fit: Patients with normal CA19-9 levels or those who are refractory to previous chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with advanced pancreatic cancer.
How similar studies have performed: Previous studies have indicated that combining chemotherapy with radiotherapy may be effective for certain pancreatic cancer patients, suggesting potential for success in 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 not refractory to previous chemotherapy and who have not received radiotherapy. * Locally advanced pancreatic cancer. * Baseline serum CA19-9 \> 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy . * 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. * 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.