Status:
RECRUITING
Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency
Lead Sponsor:
Fudan University
Conditions:
Pancreatic Adenocarcinoma
Homologous Recombination Deficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of cisplatin based regimen to patients with advanced pancreatic cancer and homologous recombination deficiency.
Detailed Description
Pancreatic adenocarcinoma (PDAC) 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. Chemothera...
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 advanced pancreas adenocarcinoma.
- Tumor progression after at least one line of chemotherapy.
- Genetic or molecular test confirmed the presence of homologous recombination deficiency.
- 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
- Pregnant or nursing women.
- Primary pancreatic cancer.
- Patients who have received platinum or PARPi treatment.
- 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 cisplatin or other platinum drugs.
- Patients who are unwilling or unable to comply with study procedures.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06095141
Start Date
December 1 2023
End Date
October 31 2026
Last Update
August 7 2025
Active Locations (1)
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1
Shanghai Cancer Center
Shanghai, China