Gastric/Esophagogastric Combination Adenocarcinoma
Conditions
Interventions
Test group:TAS102 (trefluridine tepidopyrimidine) 35 mg/m^2, orally within 1 hour after breakfast and dinner, twice daily, on days 1-5 and 8-12 of the course of treatment, for a 28-day course of treat
Apatinib mesylate tablets 250 mg orally once daily, half an hour after a meal with warm boiled water, administered continuously until PD, intolerable toxicity, subject-initiated withdrawal, and subjec
Sponsors
The First Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before enrollment; 2. Age > 18 years, both sexes; 3. histologically confirmed advanced gastric/esophagogastric union adenocarcinoma; 4. having a measurable lesion (=10 mm long diameter on CT scan for non-lymph node lesions and =15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria); 5. ECOG PS score: 0 to 1; 6. Expected survival is greater than 12 weeks; 7. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): (1) Blood routine: neutrophil >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >= 90g/L; (2) Liver and kidney function: serum creatinine (SCr) = 50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) = 2+, 24-hour urine protein quantification must show protein <= 1g; 8. Normal coagulation function, no active bleeding and thrombosis disease: International Normalized Ratio INR <=1.5×ULN; Partial thromboplastin time APTT <=1.5×ULN; Prothrombin time PT <=1.5×ULN; 9. Non-surgically sterilized or female patients of childbearing potential need to use a medically approved contraceptive method (e.g., intrauterine device, birth control pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment period; non-surgically sterilized female patients of childbearing potential must have had a negative serum or urine HCG test for 7 days prior to study enrollment and must not be breastfeeding; non-surgically sterilized or male patients of childbearing potential need to give consent to their spouse to stay in the study during the study treatment period. Male patients who are non-surgically sterilized or of childbearing age will be required to agree to use a medically approved form of contraception with their spouse for the duration of study treatment and for 3 months after the end of the study treatment period. 10. Subjects voluntarily enroll in the study, are compliant, and cooperate with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with prior or concurrent other malignancies confirmed by histologic or cytologic examination to contain other pathological components, such as squamous cell carcinoma and undifferentiated carcinoma; 2. Subjects with a known history of hypersensitivity to TAS102, apatinib or its components; 3. subjects with prior treatment with apatinib or TAS102 as first or second line therapy; 4. patients who have received other systemic anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.) within 28 days prior to study enrollment. 5. Subjects with severe organ dysfunction: severe abnormalities of liver function (e.g., ALT, AST, total bilirubin significantly higher than normal range); severe abnormalities of renal function (e.g., creatinine clearance significantly reduced or requiring dialysis treatment); severe impairment of cardiac function (e.g., clinically significant heart failure, history of myocardial infarction, or unstable angina pectoris); 6. patients with confirmed brain or spinal cord metastases (unless treatment has been completed and the patient is asymptomatic). 7. subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) and who are continuing to use it within 2 weeks prior to enrollment; 8. clinically symptomatic ascites or pleural effusion requiring therapeutic puncture or drainage; 9. subjects with severe gastrointestinal disorders (e.g., active gastrointestinal ulcers, intestinal obstruction, inability to eat, or severe nausea and vomiting that do not ensure absorption of oral medications); 10. Subjects with severe myelosuppression: hemoglobin (Hb) 38.5 degrees during the screening period, prior to the first dose of the drug (at the investigator's discretion, subjects with fever arising from a tumor may be enrolled); 13. patients with previous and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function; 14. Subjects with congenital or acquired immune function defects, such as HIV-infected patients, or active hepatitis (aminotransferases do not meet the enrollment criteria, reference for hepatitis B: HBV DNA >= 1000 IU/ml; reference for hepatitis C: HCV RNA >= 1000 IU/ml); chronic hepatitis B viral carriers, with HBV DNA <2000 IU/ml, who must receive concomitant Antiviral therapy must be received concurrently during the trial before enrollment; 15. live vaccination less than 4 weeks prior to study drug administration or possibly during the study; 16. subjects with a known history of psychotropic substance abuse, alcoholism or drug addiction; 17. the subject has received herbal medicine within 4 weeks prior to the first treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Disease control rate;Objective mitigation rate; | — |
Countries
China
Contacts
Public ContactYusheng Wang
Department of Oncology and Gastroenterology, The First Hospital of Shanxi Medical University
Outcome results
None listed