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Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
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.
Official title: Prospective, Open-label, Single-arm Clinical Study of Irinotecan Liposomes Combined With Cindilizumab and Lunvalatinib as Second-line Treatment for Adenocarcinoma of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-07-15
Completion Date
2027-10-15
Last Updated
2024-07-12
Healthy Volunteers
No
Conditions
Interventions
Irinotecan Hydrochloride Liposome Injection
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.
Locations (1)
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China