Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

NCT06499610 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024-102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Irinotecan lipoposomes; And adenocarcinoma of advanced gastric cancer and gastroesophageal junction; Second line treatment

Outcome Measures

Primary Outcomes (1)

• Intracranial progression-free survival

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

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

Secondary Outcomes (4)

• Intracranial Objective response rate

  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

  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

  The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.

• Safety/Adverse event

  From the recorded first treatment to 4 weeks after the recorded last treatment

Study Arms (1)

experimental group

EXPERIMENTAL

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

Drug: Irinotecan Hydrochloride Liposome Injection

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.

Also known as: Sintilimab Injection, Lenvatinib Mesilate Capsules

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Failure or intolerance of previous first-line anti-tumor therapy;
• CPS 1 was detected by PD-L1 expression level;
• According to RECIST1.1 criteria, the patient has at least one measurable diameter target lesion (long diameter of tumor lesion CT scan 10mm, short diameter of lymph node lesion CT scan 15mm and scanning layer thickness of 5mm);
• Bone marrow function: neutrophils 1.5109 / L, platelets 100109 / L, and hemoglobin 75g / L;
• The ECOG score is 0-2 points;
• Liver and kidney function: upper limit of 1.5 times normal value of serum creatinine; upper limit of normal value of AST and ALT (upper limit of normal value of 5 times for patients with liver invasion); upper limit of normal value of total bilirubin (upper limit of normal value of 3 times for patients with liver invasion);
• Women of childbearing age must have a negative pregnancy test (serum) within 7 days before enrollment, and must be willing to use appropriate methods for contraception during the trial;
• Consent to provide the histological samples;

You may not qualify if:

• 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.);
• Patients with intestinal obstruction and gastrointestinal bleeding;
• According to the HER 2 testing process and evaluation criteria in CSCO Guidelines for Diagnosis and Treatment of Gastric Cancer 2024 edition: confirmed by immunohistochemistry (IHC), HER2 2 + accompanied by in situ hybridization with gene amplification or HER2 3 +;
• Have any active autoimmune disease or a history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, and reduced thyroid function (which can be included after normal hormone replacement therapy);
• Heart function and disease are one of the following:
• Long QTc syndrome or QTc interval\> 480 ms;
• Complete left bundle branch block, degree II or III atrioventricular block;
• Severe, uncontrolled arrhythmias requiring medical therapy;
• New York Society of Cardiology grade III;
• Cardiac ejection fraction (LVEF) below 50%;
• history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
• Uncontrolled ascites and abdominal cavity infection;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; lenvatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Enxiao Li, doctor

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enxiao Li, doctor

CONTACT

18991232168; doclienxiao@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Medicinae

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)