Gastric Cancer
Conditions
Interventions
Research group:Trifluridine/Tipiracil Tablets: Oral 30 mg/m2, bid, d1-5, d8-12, q4wks. Anti-angiogenic drugs: Investigator's choice (Bevacizumab, Fruquintinib, Regorafenib), select appropriate dose b
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to performing any study-specific procedures required by the research; 2. Age >=18 years old on the day of signing the informed consent form, both male and female; 3. Histologically or cytologically confirmed unresectable advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Subjects must have received all standard treatment regimens recommended by current authoritative guidelines and have documented evidence of treatment failure (including treatment failure, disease progression, or intolerance) to these therapies at screening to be eligible for the study; 5. According to RECIST v1.1 criteria, subjects must have at least one measurable tumor lesion; previously irradiated lesions or locally treated measurable lesions can be selected as target lesions if imaging demonstrates disease progression; 6. ECOG performance status score of 0-2; 7. Expected survival >=3 months 8. Normal function of major organs in subjects, with basically normal results in blood tests, liver and kidney function, and cardiac function; 9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraceptive methods during the study and for 120 days after the last dose of study medication, such as abstinence, double-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc; 10. Patients who are considered by the investigator to potentially benefit from the study.
Exclusion criteria
Exclusion criteria: 1. Histopathological or cytological examination confirms the presence of other pathological components, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc; 2. HER-2 expression status is positive; 3. Presence of active malignancy within the past 3 years (excluding curable malignancies that have received curative treatment, such as cutaneous squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, or breast carcinoma in situ); 4. Currently participating in another clinical study, unless it is an observational, non-interventional study or the follow-up phase of an interventional study; 5. Known presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression. 6. Subjects with active hepatitis B virus (HBV) infection, inactive or asymptomatic HBV carriers (HBsAg positive with HBV DNA >500 IU/mL or >2500 copies/mL), and subjects with active hepatitis C virus (HCV) infection should be excluded. Inactive or asymptomatic carriers, as well as treated and stable HBV subjects meeting HBV DNA 150 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy, and active bleeding, pulmonary hemorrhage, hemoptysis, or bloody ascites; 15. History of gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis, or other gastrointestinal diseases that may lead to bleeding or perforation; 16. Patients with a history of grade 4 venous thromboembolism (including pulmonary embolism); 17. Severe uncontrolled recurrent infections, including intra-abdominal infections, or other severe uncontrolled comorbidities (e.g., uncontrolled diabetes, cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Overall survival;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactHuihui Zeng
The First Affiliated Hospital of Bengbu Medical University.
Outcome results
None listed