Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer
NCT Number: NCT06486545
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Advanced Gastric Cancer
Interventions: DRUG: Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound)
Sponsor: Hunan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2026-01-30

Summary:
Liposomal irinotecan, intravenous infusion 90min, d1:

Grade 1:50mg/m2 Grade 2:60mg/m2 Grade 3:70mg/m2 Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).

Primary Outcome Measures: Maximum tolerated dose, To estimate the maximum tolerated dose of liposomal irinotecan in the combination regimen based on dose-limiting toxicity, From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan.
Secondary Outcome Measures: Dose-limiting Toxicity (DLT) of liposomal irinotecan, One or more adverse events that occurred during the DLT observation period related to the investigational drug (including definitely related, likely related, possibly related) (meeting the DLT criteria), From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan.|Objective response rate, Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using lnvestigator assessments, is defined as the number (%) of paients of Complete Response or Partial Response, will be assessed up to 2 years., Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.|Disease control rate, The percentage of subiects of Complete Response (CR) or Parial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the investigator, will be assessed up to 2 years., Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.|Progression-free survival, Progression-free survival (PFS) is defined as the time from first dose of Liposomal irinotecan recorded until the date of disease progression based on investigator assessment., Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.|Overall survival, Overall survival is defined as the time from begining of Liposomal irinotecan treatment until death due to any cause and wil be assessed up to 3 years., The time from beginning of Liposomal irinotecan treatment until death due to any cause and will be assessed up to 3 years.