Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.);

Trial design

Treatments tested in this trial

  • Irinotecan Hydrochloride Liposome Injection

Treatment groups

44 Participants
are divided into 1 treatment group