Gastirc Cancer
Conditions
Interventions
test group:Apatinib + Irinotecan
Sponsors
the First Afflicated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years, male or female; 2. ECOG/PS score 0-2 points; 3. Advanced gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathology, with extravasational measurable lesions (spiral CT scan =10mm, meeting RECIST 1.1 criteria); 4. Locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; 5. Patients with advanced gastric cancer who failed first-line treatment, Note: (1) Definition of treatment failure: disease progression or tumor recurrence and metastasis after treatment, or intolerable toxicity; (2) First-line treatment including medication time = One or more chemotherapeutic drugs for one cycle or longer; Adjuvant/neoadjuvant therapy is allowed in the early stage, and if the tumor recurrence or metastasis occurs during the assisted/neoadjuvant treatment or within =24 weeks after completion, the previous adjuvant is considered / Neoadjuvant therapy is a first-line systemic chemotherapy for advanced disease; (3) allows pre-treatment is chemotherapy combined with molecular targeted drugs (except for first-line use of apatinib); 6. The estimated survival period is = 3 months; 7. The main organs function normally and meet the following requirements: (1) Blood routine examination, need to meet (no blood transfusion within 14 days): a. HB = 90g/L; b. ANC = 1.5 × 10^9 / L; c. PLT = 80 × 10^9 / L; (2) Biochemical examinations must meet the following criteria: a. BIL < 1.5 times the upper limit of normal (ULN); b. ALT and AST < 2.5 × ULN; if there is liver metastasis, ALT and AST < 5 × ULN; c. Serum Cr = 1×ULN, endogenous creatinine clearance = 50ml/ min (Cockcroft-Gault formula); 8. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and voluntarily use the appropriate method for contraception during the observation period and 8 weeks after the last administration; for men, surgery should be performed, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration; 9. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. First-line treatment with irinotecan or apatinib regimen; 2. A person who has been confirmed to be allergic to apatinib and/or its excipients; 3. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male >450 ms, female > 470 ms) and grade I cardiac insufficiency; urine protein positive patients; 4. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 5. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: local active ulcer lesions, fecal occult blood (++) can not be included; 2 months of hospitable, hematemesis history; for fecal occult blood (+) If the primary tumor of the stomach has not been surgically removed, a gastroscopy is required, such as ulcerative gastric cancer, and the main investigators believe that there may be major gastrointestinal bleeding. 6. abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 7. Patients with central nervous system metastases; 8. Pregnant or lactating women; 9. Patients with other malignancies within 5 years; 10. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 11. Patients who have participated in other drug clinical trials within 4 weeks; 12. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactJianjun Peng
the First Afflicated Hospital of Sun Yat-Sen University
Outcome results
None listed