Status:
RECRUITING
Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer
Lead Sponsor:
Fudan University
Conditions:
Metastatic Pancreatic Cancer
Terminal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of vitamin C in improving the quality of life for metastatic pancreatic cancer patients who are resistant to chemotherapy.
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.
- Tumor progression after two lines of chemotherapy.
- 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.
- The expected survival ≥ 1 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
- Active second primary malignancy or history of second primary malignancy.
- 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.
- 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 unwilling or unable to comply with study procedures.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06018896
Start Date
August 25 2023
End Date
August 15 2026
Last Update
June 6 2024
Active Locations (1)
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1
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032