stomach or gastroesophageal junction adenocarcinoma
Conditions
Interventions
One-armed clinical research,no group:Combined with chemotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old male or female; 2. The patients are diagnosed with advanced gastric cancer or gastroesophageal junction adenocarcinoma via histologic and cytology which have one measurable lesions at least. (Spiral CT scan=10mm;type-B ultrasonicX-rayMR should conform to RECIST 1.1 standard); 3. The second-line advanced cancer patients with the stomach or gastroesophageal junction adenocarcinoma; 4. ECOG PS 0-2; 5. The main viscera function of patients must be normal, and should meet the following requirements: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) 1) HB=90g/L; 2) ANC =1.5×10^9/L; 3) PLT =80×10^9/L. (2) Biochemical examination should meet the following criteria: 1) BIL <1.5 ULN); 2) ALT and AST<2.5 ULN (If patients have Liver metastasis, ALT and AST<5ULN); 3) SCr=1×ULN (Serum creatinine), CCr=50ml/min (The endogenous creatinine clearance)(The formula of Cockcroft-Gault); 6. The expected lifetime of patients should be equal to or more than 3 months; 7. The doctor decided to use Apatinib combined with chemotherapy; 8. The patients are willing to join in this study, and have signed the informed consent; 9. Women of child-bearing age must conduct pregnancy test(Serum or urine) within 7 days before enrollment,and the results should be negative.Meanwhile,the patients are willing to avoid pregnancy via appropriate method during the period of observation and within 8 weeks after the last dose; As for men,they should have a vasectomy, or they are willing to avoid pregnancy with appropriate method during the period of observation and within 8 weeks after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg), Patients who are diagnosed with II or higher level of coronary heart disease, arrhythmia(including QTc interval prolongation men> 450 ms, female> 470 ms) uncontrolled hypertension and cardiac insufficiency; 2. There are many factors which can influence the oral drug absorption (such as unable to swallow, nausea and vomit, chronic diarrhea and intestinal obstruction, etc.); 3. Special attention:patients who are faced with the risk of gastrointestinal bleeding shall not enter into groups,including: (1) Having active peptic ulcer lesions and defecate occult blood(++)cant be admitted into the study; (2) Patients who have been found with black stool and hematemesis within 3 months cant be admitted into the study; (3) As for the patients who are stool occult blood (+) and whose primary gastric tumor lesions have mot been surgical removal,patients must carry out gastroscopy. If the patients are the gastric carcinoma of ulcerative type, and the patients are considered to cause bleeding lesions by the doctor,they cant be addimited into the study; 4. Blood coagulation function is abnormol,and the patients have high risk of bleeding tendency.(INR>1.5×ULNA; PTT>1.5×ULN); CNS metastases or Brain metastases; 5. Pregnant or lactating women; 6. The other situation that doctor considered not suitable for enrolling in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Objective response rate;Disease control rates;The quality of life score; | — |
Countries
China
Contacts
Public ContactShen Bo
Jiangsu Cancer Hospital
Outcome results
None listed