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NOT YET RECRUITING
NCT07819019
PHASE2

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

Sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

View on ClinicalTrials.gov

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. Irinotecan liposome: A chemotherapy drug wrapped in tiny fat particles (liposomes) to target tumors more precisely and minimize damage to healthy tissues. 2. Fruquintinib: An anti-angiogenic medication that blocks the growth of new blood vessels feeding the tumor, cutting off its nutrient supply. 3. Sintilimab: An immune checkpoint inhibitor that helps the body's own immune system recognize and attack cancer cells. The primary goal of this study is to evaluate how well this three-drug combination works and to monitor its safety. Participants will receive the study drugs via intravenous infusion or oral tablets according to the protocol. Their progress will be tracked with CT scans and blood tests every three months. Regular follow-up visits will continue even after stopping treatment to monitor long-term outcomes. Who can participate? Participants must be adults diagnosed with advanced gastric cancer who have progressed after only one prior first-line standard therapy, have PD-L1-positive tumors, and have no severe heart, liver, or kidney disease. Pregnant or breastfeeding women cannot participate. Possible side effects Potential side effects may include nausea, vomiting, diarrhea, hand-foot swelling, low blood cell counts (which can increase infection risk), and fatigue. The research team will closely monitor all participants and provide prompt treatment for any side effects. Important note This study is still in the clinical trial phase. While it offers a potential new treatment option beyond standard care, there is no guarantee that the drugs will be effective for every participant. For more information, please contact the research team.

Official title: A Phase II Clinical Study of Irinotecan Liposome Combined With Fruquintinib and Sintilimab as Second-Line Therapy for PD-L1-Positive (CPS ≥ 1) Advanced Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-10-01

Completion Date

2030-10-01

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

Fruquintinib

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

BIOLOGICAL

Sintilimab

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

DRUG

Irinotecan Hydrochloride Liposome Injection (II)

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