A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT04571489
- Lead Sponsor
- Lee's Pharmaceutical Limited
- Brief Summary
This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gimatecan group Gimatecan All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD). placebo group gemcitabine All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD). placebo group tegafur, gimeracil and oteracil potassium All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD).
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months. The 2-year progression free survival of the whole group.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months. The 2-year overall survival of the whole group.
Objective response rate (ORR) To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months. Percentage of patients with objective response assessed by best overall.
Duration of Response (DoR) First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).
Disease control rate (DCR) To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months. Percentage of patients with disease control as assessed by best overall.
Patient-reported outcome (PRO) To evaluate every 6 weeks after the initiation of chemotherapy, up to 24 months. Change from baseline assessed according to the quality of life questionnaire C30.
Trial Locations
- Locations (1)
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China