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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 210 participants in total. It began in 2024-05-15 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Guopei Luo, MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06250972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06250972 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 210 participants.
Is NCT06250972 currently recruiting?
Yes, NCT06250972 is actively recruiting participants. Contact the research team at yangying@fudanpci.org for enrollment information.
Where is the NCT06250972 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06250972 clinical trial?
NCT06250972 is sponsored by Fudan University. The principal investigator is Guopei Luo, MD at Fudan University. The trial plans to enroll 210 participants.