Liposomal Irinotecan Combined with Sintilimab for Second-line Treatment of Progressive Gastric Cancer

Liposomal Irinotecan in Combination with Sintilimab in Second-Line Treatment of Progressive Gastric Cancer, a Single-Arm, Single-Center, Open-Label, Phase II Clinical Study

Evaluating the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressive gastric cancer

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Irinotecan liposome injection Ⅱ; Drug: Sintilimab

Detailed Description

This is a single-center, open, single-arm clinical study to evaluate the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressed gastric cancer, and to provide more clinical treatment options for gastric cancer patients.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hao Li, MD, PhD; Phone Number: 15000660260; Email: lh11001@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years old, gender is not limited;
2. Pathologically confirmed adenocarcinoma (originating from the stomach and gastroesophageal junction);
3. Clinical documentation of failure of prior standard therapy (treatment with at least 1 cycle of standard chemotherapy regimen, disease progression or intolerance during treatment, or disease progression after completion of treatment).
4. An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;

5. Have equivalent organ function, i.e., meet the following criteria:

   a.Routine blood tests:

   1. Neutrophils ≥ 1.5 × 109 /L;
   2. Leukocytes ≥ 3.5 × 109 /L;
   3. Platelets ≥ 75 × 109 /L;
   4. hemoglobin ≥70 g/L; b. Biochemical examination:
   1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (subjects with biliary obstruction, after biliary drainage ≤ 5 × ULN);
   2. ≤ 5 x ULN for alanine aminotransferase (AST) and alanine aminotransferase (ALT) in subjects with liver metastases
   3. Albumin level ≥ 28 g/L;
   4. creatinine clearance ≥ 60 ml/min; c.Cardiac function tests:
   1. normal ECG or abnormal ECG (not clinically significant in the judgment of the investigator)
   2. Left ventricular ejection fraction (LVEF) ≥ low limit of normal;
6. Previous surgery, radiotherapy, chemotherapy or other anti-tumor treatment need to end the treatment for 4 weeks or more, and the general physical condition or related adverse reactions have recovered (toxic reaction ≤ grade 1) or reached a stable state;
7. Participate voluntarily and sign the informed consent form;
8. Good compliance, agree to cooperate with the survival follow-up.

Exclusion Criteria:

1. Patients previously treated with irinotecan;
2. Subjects with ascites requiring clinical intervention (including subjects with moderate to large amounts of ascites, if the subject's ascites needs to be stabilized for more than 4 weeks after drainage);
3. Clinically significant gastrointestinal-like illness (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
4. second primary malignant tumor within 5 years (except for cured carcinoma in situ, basal or squamous cell skin cancer; subjects with other previous neoplasms that have not recurred within 5 years may be enrolled);
5. Suffering from uncontrolled cardiac or cerebral diseases or clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmia requiring treatment or intervention; ⑤ uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after optimal treatment) ;
6. Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥ 103 copies or ≥ 1000 U/ml);
7. Active infection or unexplained fever >38.5°C during the Screening Period or on the day of dosing (in the investigator's judgment, fever due to neoplasia may be enrolled), which, in the investigator's judgment, would interfere with the subject's participation in this trial or interfere with the evaluation of efficacy;
8. Known hypersensitivity to any component of irinotecan hydrochloride liposomes or other liposomes;
9. Pregnant or lactating women;
10. Positive screening blood (urine) pregnancy test in women of childbearing potential (male and female subjects should use reliable contraception to prevent pregnancy during the trial and for 3 months after the last dose);
11. other medical or social problems that, in the judgment of the investigator, may affect the subject's ability to sign an informed consent, to participate in the trial study, or to influence the interpretation of the trial results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treatment; The patients with Progressive Stage Gastric Cancer will be enrolled and given Sintilimab: 200 mg over 1 hour IV, given every 3 weeks. Irinotecan Liposome Injection II: 56.6 mg/m2 (free base) every 3 weeks, depending on the dose. Sequence of administration: Sindilizumab and Irinotecan Liposome Injection II will be given sequentially. Pre-treatment medication: Dexamethasone and antiemetic (or prophylactic irinotecan if preferred according to hospital practice).

Drug: Irinotecan liposome injection Ⅱ; 56.6 mg/m2，Q3W; Drug: Sintilimab; 200mg，Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate,ORR	the best response rate	up to two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival,PFS	from first dose treatment to disease progression	up to two years
Disease control rate,DCR	Proportion of cases with complete remission, partial remission and stabilization of lesions	up to two years
adverse events, AE	treatment related adverse events, TRAEs	up to two years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Hao Li, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: gastric cancer; Sintilimab; second-line treatment; irinotecan liposome
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Irinotecan
• Other Study ID Numbers: 24-OBU-SH-GC-Ⅱ-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The researchers decided not to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No