gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
The treatment group:PD1 inhibitor (cindilizumab) combined with docetaxel
Sponsors
Shanxi Provincial Tumour Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) age: 18-75 years old, male and female; (2) histopathologically diagnosed advanced gastric/gastroesophageal junction adenocarcinoma with measurable lesions (spiral CT scan >= 10mm, meeting RECIST1.1 standard); (3) failed first-line chemotherapy, and paclitaxel was not used in the first-line; (4) ECOG PS: 0-2 points; (5) the main organs function normally and meet the following requirements: A. Routine blood examination should meet the requirements (no blood transfusion within 14 days) : a. HB>=90g/L;b. the ANC acuity 1.5 x 10^9 / L; c. PLT >= 80x10^9/L B, biochemical examination should meet the following standards: a. BIL = 50ml/min (Cockcroft-Gault formula) (6) expected survival time >= 3 months; (7) the patient voluntarily joined the study and signed the informed consent (ICF); (8) women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib tablets;For men, surgical sterilization should be performed or appropriate methods of contraception should be agreed to during the observation period and within 8 weeks after the last apatinib tablet.
Exclusion criteria
Exclusion criteria: (1) patients with hypertension, the antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg), suffering from II or higher level of coronary heart disease, arrhythmia (> 450 ms, including QTc lengthened men women > 470 ms) and cardiac insufficiency. (2) patients with an obvious history of allergy; (3) there are bleeding, perforation, obstruction and other patients requiring emergency surgical treatment; (4) patients with severe organ failure and interstitial pneumonia; (5) central nervous system metastasis with symptoms; (6) pregnant or lactating women; (7) other patients who are not suitable for inclusion according to the treatment physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactYusheng Wang
Shanxi Provincial Tumour Hospital
Outcome results
None listed