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.
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.
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.).
Long QT syndrome or QTc interval > 480 ms;
Complete left bundle branch block, or second- or third-degree atrioventricular block;
Single group
Fruquintinib
Drug3 mg orally once daily on days 1-7, followed by 7 days off (1 week on, 1 week off), in repeated cycles.
Sintilimab
Biological/Vaccine200 mg administered by intravenous infusion on day 1 of each 21-day cycle.
Irinotecan Hydrochloride Liposome Injection (II)
Drug56.5 mg/m2 administered by intravenous infusion over 90 minutes on day 1 of each 14-day cycle.
PFS
progression-free survival
ORR
Objective Response Rate
DCR
Disease control rate
OS
Overall survival
Safety and Tolerability
Incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), graded according to CTCAE version 5.0, including AEs leading to dose delay, dose reduction, or treatment discontinuation.
Click on the lead sponsor to view all of their trials.
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
