gastrointestinal tumor
Conditions
Interventions
test group:Apatinib oral 500-750mg / day
Sponsors
Oncology Department of Beijing Luhe Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 years old to 75 years old, male or female; (2) by histopathology and / or cytology diagnosed with advanced gastrointestinal cancer, digestive tract having measurable disease (spiral CT scan =10mm, meet RECIST 1.1 criteria); (3) = 1 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 treatment of each line of advanced disease 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; (4) ECOG PS: 0-3 points; (5) major organs functioning; (6) expected survival =3 months; (7) the treating physician plans to use the APA imatinib mesylate tablets therapy; (8) patients voluntarily joined the study, and informed consent (ICF); (9) women of childbearing age must be enrolled in the 7 days before a pregnancy test (serum or urine) results were negative, and the voluntary during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception; for men should be surgical sterilization, or agreed during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception.
Exclusion criteria
Exclusion criteria: (1) People with hypertension, the antihypertensive drug therapy can not be reduced to the normal range (systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg), with =II level of coronary heart disease, arrhythmia (including QTc interval prolongation men> 450 ms, female> 470 ms) and heart failure; (2) with a variety of factors affecting oral drug absorption (eg unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); (3) pay particular attention to: the risk of gastrointestinal bleeding in patients with a non-enrolled, including the following: (1) with active peptic ulcer lesions and fecal occult blood (+); black (2) 3 months will , a history of vomiting; (3) for fecal occult blood (+) - and the primary gastric tumor lesions did not undergo surgery, the need for endoscopy, such as gastric ulcer, and the treating physician believes it may cause bleeding lesions By; (4) coagulopathy (INR> 1.5 × ULN, APTT> 1.5 × ULN), have bleeding tendencies; (5) central nervous system with symptoms transfer; (6) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficativeness;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;side effect; | — |
Countries
China
Contacts
Public ContactLi Xuebing
Beijing Luhe Hospital, Capital Medical University
Outcome results
None listed