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.
This study is an exploratory clinical study. It is expected to include 44 patients with second-line advanced gastric and gastroesophageal junction adenocarcinoma, all treated with irinotecan liposome combined with cindilizumab and lunvatinib. The dosing regimen of irinotecan liplex injection was 70 mg / m2, cindilizmab 200mg, and valatinib 8-12mg (dose determined by body weight), every 3 weeks, every 2 treatment cycles (every 6 weeks). The subject is scheduled to receive 6 cycles of treatment, or develop intolerable toxicity, or terminate the study for other reasons. The study included screening period (within 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
At 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.
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Intracranial progression-free survival
Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the recorded first treatment to 4 weeks after the recorded last treatment
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