gastric cancer
Conditions
Interventions
one-armed clinical research,no group:apatinib mesylate combined with irinotecan
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed with advanced gastric cancer with one measurable lesions at least (Spiral CT scan=10mm; type-B ultrasonicX-rayMR should conform to RECIST 1.1 standard); 2. Aged 18-75 years old male or female; 3. The first line chemotherapy in patients with advanced gastrointestinal tumors failed; Definition: (1) of treatment failure: after the end of treatment to disease progression or treatment of tumor recurrence and metastasis, or unacceptable toxicity occurred; (2) the first line treatment include medication or cycle time =1 longer one or more chemotherapeutic agents; allows pre-adjuvant / neoadjuvant therapy, if the auxiliary / neoadjuvant therapy during or after completion of = 24 weeks appears tumor recurrence and metastasis, is considered pre auxiliary / neoadjuvant therapy It is a progression of the disease for the first-line systemic chemotherapy; (3) allows early treatment is chemotherapy and molecular targeted drugs(except apatinib); 4. ECOG PS 0-2; 5. The expected lifetime of patients should be equal to or more than 3 months; 6. 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) HB=90g/L; ANC =1.5×10^9/L; PLT =80×10^9/L; (2) Biochemical examination should meet the following criteria: BIL <1.5 ULN); ALT and AST<2.5 ULN (If patients have Liver metastasis, ALT and AST<5ULN); SCr=1×ULN (Serum creatinine), CCr=50ml/min (The endogenous creatinine clearance)(The formula of Cockcroft-Gault); 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. Note: The pleural effusion caused by metastasis can be used as non-target lesions.
Exclusion criteria
Exclusion criteria: 1. The first line treatment contained irinotecan or apapatinib; 2. 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; 3. 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.); 4. 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; 5. Blood coagulation function is abnormol,and the patients have high risk of bleeding tendency.(INR>1.5×ULNA; PTT>1.5×ULN); 6. CNS metastases or Brain metastases; 7. Pregnant or lactating women; 8. The other situation that doctor considered not suitable for enrolling in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;progression free survival; | — |
Countries
China
Contacts
Public ContactChen Ling
Fujian Cancer Hospital
Outcome results
None listed