Status:
ACTIVE_NOT_RECRUITING
Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer
Lead Sponsor:
Fudan University
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemothe...
Detailed Description
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of th...
Eligibility Criteria
Inclusion
- 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 metastatic pancreas adenocarcinoma.
- Adequate organ performance based on laboratory blood tests.
- Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- Hemoglobin (Hgb) ≥ 8 g/dL.
- The expected survival ≥ 3 months.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion
- Patients who have received any form of anti-tumor therapy.
- The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- Pregnant or nursing women.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc).
- Renal insufficiency or dialysis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study.
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
- Patients who are unwilling or unable to comply with study procedures.
Key Trial Info
Start Date :
August 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06018883
Start Date
August 20 2023
End Date
August 15 2026
Last Update
August 7 2025
Active Locations (1)
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1
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032