Patients with locally advanced or metastatic gastric adenocarcinoma who have failed first-line chemotherapy
Conditions
Interventions
experimental group:Apatinib mesylate tablets: 250 mg, P.O, qd
TAS-102 (Trafluorouracil Tepirimil Tablets): 35 mg/m2, P.O, bid, d1-d5, q2w
Sponsors
Xiamen University Affiliated Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, male or female; 2. Gastric adenocarcinoma confirmed by pathology (including histology or cytology), including papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signet ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR, and unresectable locally advanced or metastatic (stage IV) tumors; 3. Patients with advanced gastric cancer who have undergone standard first-line treatment in the past need to have a 1-month interval between the last chemotherapy; 4. Have not previously received treatment regimens containing apatinib mesylate or other anti angiogenic drugs, TAS-102 (trafluuridine and tipirizine tablets); According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length = 10mm, lymph node lesion CT scan short diameter = 15mm, scan layer thickness 5mm); 6. ECOG PS score: 0-2 points; 7. Expected survival time = 3 months; 8. The damage caused by the subjects receiving other treatments has recovered, with an interval of = 6 weeks between receiving nitroso or mitomycin; Received other cytotoxic drugs, radiation therapy, or surgery for = 4 weeks, and the wound has fully healed; 9. The main organs function normally and meet the following standards: (1) The standard for blood routine examination must comply with: (no blood transfusion within 14 days) a. HB = 90g/L, b. WBC = 3.5 × 109/L c. ANC = 1.5 × 109/L, d. PLT = 75 × 109/L; (2) Biochemical examination must meet the following standards: a. BIL50ml/min (Cockcroft Goult formula); 10. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the investigational drug; For males, surgical sterilization should be performed, or appropriate methods of contraception should be agreed during the trial period and 8 weeks after the last administration of the investigational drug; 11. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Age: 18-75 years old, male or female; 2. Gastric adenocarcinoma confirmed by pathology (including histology or cytology), including papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signet ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR, and unresectable locally advanced or metastatic (stage IV) tumors; 3. Patients with advanced gastric cancer who have undergone standard first-line treatment in the past need to have a 1-month interval between the last chemotherapy; 4. Have not previously received treatment regimens containing apatinib mesylate or other anti angiogenic drugs, TAS-102 (trafluuridine and tipirizine tablets); According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length = 10mm, lymph node lesion CT scan short diameter = 15mm, scan layer thickness 5mm); 6. ECOG PS score: 0-2 points; 7. Expected survival time = 3 months; 8. The damage caused by the subjects receiving other treatments has recovered, with an interval of = 6 weeks between receiving nitroso or mitomycin; Received other cytotoxic drugs, radiation therapy, or surgery for = 4 weeks, and the wound has fully healed; 9. The main organs function normally and meet the following standards: (1) The standard for blood routine examination must comply with: (no blood transfusion within 14 days) a. HB = 90g/L, b. WBC = 3.5 × 109/L c. ANC = 1.5 × 109/L, d. PLT = 75 × 109/L; (2) Biochemical examination must meet the following standards: a. BIL50ml/min (Cockcroft Goult formula); 10. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the investigational drug; For males, surgical sterilization should be performed, or appropriate methods of contraception should be agreed during the trial period and 8 weeks after the last administration of the investigational drug; 11. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. 12. There are many factors affecting oral medicine (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea and Bowel obstruction); 13. Those who are allergic to the experimental drug or its excipients; 14. Researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;Progressive free survival time;Overall survival; | — |
Countries
China
Contacts
Public ContactXiao Li
Xiamen University Affiliated Zhongshan Hospital
Outcome results
None listed