A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer

NCT07819019 | Not Yet Recruiting Phase 2

• 1 other identifier: IFS-GC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

English Translation (for ClinicalTrials.gov Patient-Friendly Summary): This is a Phase II clinical trial for patients with advanced gastric cancer (stomach cancer). We are looking for participants whose cancer has progressed after one prior standard chemotherapy regimen and whose tumors test positive for the PD-L1 protein. This study is testing the effectiveness of a combination of three medications:

1. 1.Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues.
2. 2.Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply.
3. 3.Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells.

Conditions

Stomach Neoplasms; Gastric Cancer

Keywords

irinotecan hydrochloride liposome; gastric cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  From date of first dose until the date of first documented progression or death from any cause, whichever came first, assessed up to 12 months.

Secondary Outcomes (4)

• ORR

  Every 6 weeks from baseline until disease progression or initiation of subsequent anti-cancer therapy, assessed up to 12 months

• DCR

  Every 6 weeks from baseline until disease progression, assessed up to 12 months

• OS

  From date of first dose until date of death from any cause, assessed up to 12 months.

• Safety and Tolerability

  From date of first dose through 30 days after last dose, assessed up to 13 months.

Study Arms (1)

Fruquintinib + Sintilimab + Liposomal Irinotecan

EXPERIMENTAL

Fruquintinib + Sintilimab + Liposomal Irinotecan

Drug: Fruquintinib; Biological: Sintilimab; Drug: Irinotecan Hydrochloride Liposome Injection (II)

Interventions

Fruquintinib DRUG

3 mg orally once daily on days 1-7, followed by 7 days off (1 week on, 1 week off), in repeated cycles.

Fruquintinib + Sintilimab + Liposomal Irinotecan

Sintilimab BIOLOGICAL

200 mg administered by intravenous infusion on day 1 of each 21-day cycle.

Fruquintinib + Sintilimab + Liposomal Irinotecan

Irinotecan Hydrochloride Liposome Injection (II) DRUG

56.5 mg/m2 administered by intravenous infusion over 90 minutes on day 1 of each 14-day cycle.

Fruquintinib + Sintilimab + Liposomal Irinotecan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who fully understand the study and voluntarily sign the informed consent form (ICF).
• Age ≥ 18 years and ≤ 80 years.
• Patients with histopathologically confirmed unresectable or metastatic gastric cancer, with positive PD-L1 expression (CPS ≥ 1).
• Radiologically confirmed disease progression after prior first-line standard therapy.
• At least one measurable target lesion according to RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
• Life expectancy ≥ 3 months.
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, and hemoglobin ≥ 90 g/L (with no blood transfusion, no blood products, and no use of granulocyte colony-stimulating factor or other hematopoietic growth factors for correction within 14 days prior to laboratory testing).
• Hepatic and renal function: serum creatinine ≤ 1.5 × the upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver metastases).
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of study drug.

You may not qualify if:

• Hypersensitivity to any study drug or its components.
• Concurrent severe uncontrolled infection or other severe uncontrolled concomitant diseases, or moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.).
• Cardiac function and diseases meeting any of the following:
• Long QT syndrome or QTc interval \> 480 ms;
• Complete left bundle branch block, or second- or third-degree atrioventricular block;
• Severe uncontrolled arrhythmia requiring medication;
• New York Heart Association (NYHA) class ≥ III;
• Left ventricular ejection fraction (LVEF) \< 50%;
• Myocardial infarction, unstable angina, history of severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormality.
• Active hepatitis B or hepatitis C infection (hepatitis B surface antigen positive and hepatitis B virus DNA \> 1 × 10\^3 copies/mL; hepatitis C virus RNA \> 1 × 10\^3 copies/mL); asymptomatic chronic hepatitis B or hepatitis C carriers may be exempted.
• Human immunodeficiency virus (HIV) infection (HIV antibody positive).
• Radiologically confirmed intestinal obstruction.
• History of or concurrent other malignancies (except adequately controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment within the past five years).
• Pregnant or lactating women, and patients of childbearing potential who are unwilling to use contraception.
• Patients with other concurrent malignancies requiring treatment.

Sponsors & Collaborators

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: lead
• Shanghai Hengrui Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; sintilimab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Junjie Hang

CONTACT

136 8170 9736; katerhjj0000@126.com

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: Attending Physician, Department of Medical Oncology

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: September 14, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share