HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Case series:Combined use of pyrotinib and apatinib
Sponsors
Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 years old male and female; (2) Confirmed as gastric or gastroesophageal junction adenocarcinoma by histology and/or cytology; (3) Her-2 test shows positive results(IHC method 3+; or IHC method 2+ and FISH method +); (4) Advanced or metastatic gastric/gastroesophageal junction adenocarcinoma, previously treated with trastuzumab +/- chemotherapy or not; (5) Abdominal radiotherapy for advanced tumors has not been received; (6) There are imaging evaluable lesions that can be evaluated in accordance with RECIST 1.1; (7) ECOG score 0-1 points; (8) Expected survival more than 3 months; (9) Laboratory examinations must meet treatment criteria within 7 days prior to enrollment; (10) All patients must agree to take effective contraceptive measures during the study period and within 30 days after finishing the treatment. Female patients of childbearing age must have a negative urine pregnancy test prior to treatment; (11) Subjects (or their legal representatives/guardians) must sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) It has been confirmed that allergic to pyrotinib maleate tablets and apatinib mesylate tablets and/or their excipients; (2) Liver function tests: total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are higher than 2.5 times the normal upper limit. If due to liver metastasis, the above indicators are higher than 5 times the normal upper limit; Renal function test: serum creatinine (Cr) is higher than 2 times the normal upper limit; (3) patients with contraindications to apatinib (Patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, 30 days after major surgery, uncontrollable hypertension, grade III-IV cardiac insufficiency, severe liver and kidney dysfunction are disabled); (4) Received abdominal radiotherapy previously, except for local palliative radiotherapy for bone metastases; (5) Those who used other similar drugs or participated in other clinical trials within 4 weeks before enrollment; (6) Surgery within 4 weeks prior to enrollment or not fully recovered from previous surgery; (7) Other malignant tumors now or past (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment for the past five years); (8) Severe mental illness affecting the understanding of informed consent in addition to expression or observation of adverse reactions; (9) Female patients during pregnancy or lactation and women of childbearing age who refuse to receive contraception; (10) Situations believed by investigators that may affect patients compliance, or the signing of an informed consent form, or any other disease or conditions of clinical significance that is not appropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of evaluable lesion; | — |
Countries
China
Contacts
Public ContactXianglin Yuan
Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed