Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT06499610
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride Liposome Injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 15, 2024
Status verified
Jul 2024
Primary completion
Oct 15, 2027
Completion
Oct 15, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental group
    therapeutic measure： Irinotecan hydrochloride for liposome injection 70mg/m2，intravenous drip，d1 Sintilimab Injection 200mg，intravenous drip，d1 Lenvatinib Mesilate Capsules ，8mg (weight\<60kg) or 12mg (weight≥60kg) ,po, qd

Primary Outcome Measure

Intracranial progression-free survival [ Time Frame: Intracranial progression-free survival (PFS) analysis based on investigator assessment and will be assessed up to 3 years. ]

Central Contacts

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