Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer
Recruiting · NCT06250972 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
Gemcitabine, Nab-paclitaxel, IrinotecanIntensity-Modulated Radiation Therapy (IMRT)
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Shanghai Cancer Center - Shanghai, Shanghai Municipality, China