Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
The purpose of this study is to evaluate the efficacy of cisplatin based regimen to patients with advanced pancreatic cancer and homologous recombination deficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cisplatin
DrugCisplatin 25 mg/m2, ivgtt, 30 min, D1, 8. The administration of other chemotherapeutic agents including gemcitabine, nab-paclitaxel, fluorouracil, irinotecan, capecitabine is applied according to the National Comprehensive Cancer Network (NCCN) guideline. PARP inhibitor will be recommended to patients with platinum-sensitive metastatic PDAC after six months of cisplatin based regimen.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CisplatinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
progression-free survival, PFS
PFS of subjects from recruiting to the time of disease progression
Time frame
At the end of Cycle 1 (each cycle is 21 days)Secondary outcomes
1
objective response rate (ORR)
CR + PR
Time frame
At the end of Cycle 1 (each cycle is 21 days)2
disease control rate (DCR)
CR + PR + SD
Time frame
At the end of Cycle 1 (each cycle is 21 days)3
Overall survival，OS
OS of subjects from recruiting to the time of death from any cause
Time frame
At the end of Cycle 1 (each cycle is 21 days)Sponsors and contacts
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Source ClinicalTrials.gov