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.
The patient was fully aware of the study and volunteered to participate in and signed the informed consent form (ICF);
Age≥18 years old;
Expected survival time of 3 months;
Patients with pathologically confirmed advanced gastric cancer and adenocarcinoma of the gastroesophageal junction;
Allergic reaction to any study drug or its ingredients;
Patients with severe hepatic and renal insufficiency;
Have used a strong CYP3A4 inducer within 2 weeks before the first dose of the trial drug, or have used a strong CYP3A4 inhibitor or a strong UGT1A1 inhibitor within 1 week;
Uncontrollable systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes mellitus, etc.);
Single group
Irinotecan Hydrochloride Liposome Injection
DrugAt the dose of 70mg / m2, for patients homozygous for UGT1A1 \* 28, the first dose of irinotecan was adjusted to 50mg / m2,70mg / m2 if the patient tolerated during the first cycle and 70 mg / m 2 in the subsequent cycle; add 500 mL of 5% glucose injection or 0.9% sodium chloride injection for intravenous infusion within 90 minutes. On the first day of each treatment cycle.
Intracranial progression-free survival
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
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.
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.
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.
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.
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