NCT06250972 Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer
| NCT ID | NCT06250972 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2027-05-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The purpose of this study is to evaluate the efficacy of chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not 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 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