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

NCT06697366 | Not Yet Recruiting Phase 2

• 1 other identifier: 24-OBU-SH-GC-Ⅱ-013
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastric Cancer

Keywords

gastric cancer; irinotecan liposome; Sintilimab; second-line treatment

Outcome Measures

Primary Outcomes (1)

• overall response rate,ORR

  the best response rate

  up to two years

Secondary Outcomes (3)

• progression free survival,PFS

  up to two years

• Disease control rate,DCR

  up to two years

• adverse events, AE

  up to two years

Study Arms (1)

treatment

EXPERIMENTAL

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; Drug: Sintilimab

Interventions

Irinotecan liposome injection Ⅱ DRUG

56.6 mg/m2，Q3W

treatment

Sintilimab DRUG

200mg，Q3W

treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, gender is not limited;
• Pathologically confirmed adenocarcinoma (originating from the stomach and gastroesophageal junction);
• 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).
• An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;
• Have equivalent organ function, i.e., meet the following criteria:
• a.Routine blood tests:
• Neutrophils ≥ 1.5 × 109 /L;
• Leukocytes ≥ 3.5 × 109 /L;
• Platelets ≥ 75 × 109 /L;
• hemoglobin ≥70 g/L; b. Biochemical examination:
• <!-- -->
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (subjects with biliary obstruction, after biliary drainage ≤ 5 × ULN);
• ≤ 5 x ULN for alanine aminotransferase (AST) and alanine aminotransferase (ALT) in subjects with liver metastases
• Albumin level ≥ 28 g/L;
• creatinine clearance ≥ 60 ml/min; c.Cardiac function tests:

You may not qualify if:

• Patients previously treated with irinotecan;
• 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);
• Clinically significant gastrointestinal-like illness (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
• 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);
• 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) ;
• Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥ 103 copies or ≥ 1000 U/ml);
• 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;
• Known hypersensitivity to any component of irinotecan hydrochloride liposomes or other liposomes;
• Pregnant or lactating women;
• 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);
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

irinotecan sucrosofate; sintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Hao Li

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Li, MD, PhD

CONTACT

15000660260; lh11001@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start: November 20, 2024
• Primary Completion: May 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share