Gastric Cancer, Stomach Neoplasms
Conditions
Keywords
irinotecan hydrochloride liposome, gastric cancer
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. 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.
Interventions
DRUGFruquintinib
3 mg orally once daily on days 1-7, followed by 7 days off (1 week on, 1 week off), in repeated cycles.
BIOLOGICALSintilimab
200 mg administered by intravenous infusion on day 1 of each 21-day cycle.
56.5 mg/m2 administered by intravenous infusion over 90 minutes on day 1 of each 14-day cycle.
Sponsors
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who fully understand the study and voluntarily sign the informed consent form (ICF). 2. Age ≥ 18 years and ≤ 80 years. 3. Patients with histopathologically confirmed unresectable or metastatic gastric cancer, with positive PD-L1 expression (CPS ≥ 1). 4. Radiologically confirmed disease progression after prior first-line standard therapy. 5. At least one measurable target lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 7. Life expectancy ≥ 3 months. 8. 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). 9. 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). 10. 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.
Exclusion criteria
1. Hypersensitivity to any study drug or its components. 2. 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.). 3. Cardiac function and diseases meeting any of the following: 1. Long QT syndrome or QTc interval \> 480 ms; 2. Complete left bundle branch block, or second- or third-degree atrioventricular block; 3. Severe uncontrolled arrhythmia requiring medication; 4. New York Heart Association (NYHA) class ≥ III; 5. Left ventricular ejection fraction (LVEF) \< 50%; 6. 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. 4. 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. 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive). 6. Radiologically confirmed intestinal obstruction. 7. 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). 8. Pregnant or lactating women, and patients of childbearing potential who are unwilling to use contraception. 9. Patients with other concurrent malignancies requiring treatment. 10. Patients judged by the investigator to be unsuitable for participation in this study. 11. History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5 mL of bright red blood) within 1 month prior to the first dose. 12. Arterial embolism, severe bleeding (excluding surgery-related bleeding), or severe bleeding tendency within 6 months prior to the first dose. 13. Symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, or spinal cord compression. 14. Use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1 within 14 days prior to study drug treatment. 15. Use of other investigational drugs within 1 month prior to the first dose. 16. Pregnant or lactating women, and subjects of childbearing potential who refuse contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 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. | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Every 6 weeks from baseline until disease progression or initiation of subsequent anti-cancer therapy, assessed up to 12 months | Objective Response Rate |
| DCR | Every 6 weeks from baseline until disease progression, assessed up to 12 months | Disease control rate |
| OS | From date of first dose until date of death from any cause, assessed up to 12 months. | Overall survival |
| Safety and Tolerability | From date of first dose through 30 days after last dose, assessed up to 13 months. | 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. |
Contacts
CONTACTJunjie Hang
Outcome results
None listed