Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer
NCT Number: NCT06499610
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Gastric Cancer
Interventions: DRUG: Irinotecan Hydrochloride Liposome Injection
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2027-10-15
Locations: First Affiliated Hospital of Xian Jiaotong University, Xi'an, Shaanxi, 710061, China

Summary:
This study is a single-arm, single-center, exploratory clinical study. It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib. The study unit is the First Affiliated Hospital of Xi'an Jiaotong University. The study included screening period (28 days), treatment period (6 cycles), and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.

Primary Outcome Measures: Intracranial progression-free survival, Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years., Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Secondary Outcome Measures: Intracranial Objective response rate, The number (%) of patients defined as complete or partial response, assessed using the investigator, version 1.1 (RECIST 1.1), was from the enrollment of subjects to the end of chemotherapy., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.|Intracranial Disease Control Rate, The percentage of subjects who have a best response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator, was from the enrollment of subjects to the end of chemotherapy., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.|Overall Survival, Overall survival is defined as the time from beginning of treatment until death due to any cause and will be assessed up to 3 years., The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.|Safety/Adverse event, Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice., From the recorded first treatment to 4 weeks after the recorded last treatment