Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer

NCT06437678 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB-2024-498
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  After treatment, the proportion of cancer patients whose tumors have shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of the complete response (CR) and partial response (PR) ratios.

  through study completion, an average of 1 year

• Disease Control Rate (DCR)

  The percentage of evaluable cases in cancer patients who have improved their condition (CR+PR) and stabilized their condition (SD) after treatment.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• OS (Overall survival)

  Assessed up to 60 months

Study Arms (1)

Recurrent/Refractory Advanced Gastric Cancer

OTHER

Drug: Liposomal Irinotecan Hydrochloride

Interventions

Liposomal Irinotecan Hydrochloride DRUG

Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks

Recurrent/Refractory Advanced Gastric Cancer

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily join this study and sign an informed consent form;
• Age ≥18 years and ≤75 years;
• Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
• CT or biopsy-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
• Previously received at least one line of standard first- and second-line therapy (e.g., chemotherapy, targeted therapy), and experienced disease progression or intolerance;
• Interval of ≥4 weeks since previous chemotherapy, immunotherapy, or radiotherapy;
• Expected survival of ≥12 weeks;
• ECOG performance status score of 0-2;
• Normal major organ function, meeting the following criteria:
• Hematologic criteria:
• (No blood transfusion or blood products, and no use of G-CSF or other hematopoietic growth factors within 14 days) Absolute neutrophil count ≥1.5×10\^9/L; Platelets ≥80×10\^9/L; Hemoglobin ≥80 g/L.
• Biochemical criteria:
• Total bilirubin \<1.5×ULN; ALT and AST ≤2.5×ULN (without liver metastasis) / ALT and AST ≤5×ULN (with liver metastasis); Serum creatinine ≤1.5×ULN or creatinine clearance \>50 ml/min (Male: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine); Female: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine) × 0.85; weight in kg; serum creatinine in mg/mL).
• Urine protein (semi-quantitative method) less than 2+;
• Normal coagulation function (including INR, APTT, PT, FIB).

You may not qualify if:

• Having a history of or currently suffering from other malignant tumors;
• Previous or current use of irinotecan drugs;
• Having any chronic or significant disease deemed intolerable to treatment (e.g., severe heart disease, uncontrolled hypertension, significant liver or kidney dysfunction, etc.);
• History of gastrointestinal perforation, abdominal abscess, or recent (within 3 months) bowel obstruction, or imaging or clinical symptoms indicating the presence of bowel obstruction;
• Significant clinically relevant bleeding symptoms or a clear tendency to bleed within 3 months before the first dose of the study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; if fecal occult blood is positive at baseline, retesting is allowed. If retesting remains positive, a gastroscopy is required (unless gastroscopy has been performed within the past 3 months to exclude these conditions);
• Currently undergoing treatment for an active infection (e.g., requiring antibacterial, antiviral, or antifungal therapy);
• Active hepatitis (Hepatitis B: HBsAg positive and HBV DNA ≥500 IU/ml; Hepatitis C: HCV antibody positive and HCV RNA \> upper limit of normal);
• Congenital or acquired immunodeficiency (e.g., HIV infection);
• Suffering from a mental illness that could interfere with consent or follow-up;
• Having any active autoimmune disease or a history of autoimmune disease with a risk of recurrence;
• Planned or previous organ or allogeneic bone marrow transplantation;
• Currently having interstitial pneumonia or interstitial lung disease, a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or a screening CT showing active pneumonia or severe lung dysfunction; active tuberculosis;
• Currently using or recently used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes;
• Received an attenuated live vaccine within 28 days before the first dose of the study drug, or requires such a vaccine during the treatment period or within 60 days after the last dose;
• Known allergy to any study drug or excipients;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiangdong Cheng

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Xiangdong Cheng

CONTACT

13968032995; chengxd@zjcc.org.cn

Li Yuan

CONTACT

15558103169; yuanli2768@zjcc.org.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: Chief physician

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: May 27, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)