Gastric cancer
Conditions
Interventions
Case series:camrelizumab combined with pyrotinib maleate and CapeOX
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients, age = 18 years;2. Histological or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma3. HER-2 positive definition: IHC3 + or IHC2 + with ISH (or FISH) + in the assessment of primary or metastatic tumor lesions. ISH positive is defined as the ratio of HER2 gene copy number to CEP17 signal number = 2.0;4. No serious liver and kidney damage, the functional level of the organ must meet the following requirements: ANC = 1.5 × 109 / L; PLT = 90 × 109 / L; Hb = 90 g / L; TBIL = 1 × ULN; ALT and AST = 1.5 × ULN, ALP = 2.5 × ULN; for patients with liver metastases, ALT and AST = 5 × ULN; BUN and Cr = 1 × ULN and creatinine clearance = 50 mL / min (Cockcroft-Gault formula); LVEF = 50%; Fridericia-corrected QT interval (QTcF) for males <450 ms and females <470 ms; INR = 1.5 × ULN, APTT = 1.5 × ULN.5. Patients have measurable or measurable non-measurable lesions; evaluated by researchers according to the RECIST v1.1 of solid tumors;6. The Eastern Cooperative Oncology Group Behavior State Score (ECOG PS) is 0 or 1;7. Life expectancy = 3 months;8. The investigator evaluates that the patient can comply with the protocol requirements;9. Sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Systemic cytotoxic chemotherapy for advanced (metastatic) disease; 2. There is evidence of disease progression within 6 months after neoadjuvant chemotherapy or adjuvant cytotoxic chemotherapy (or both) or radiotherapy for cancer of the gastric or gastroesophageal junction; 3. Previous use of any her2-targeted drug therapy (including but not limited to trastuzumab, lapatinib, pyrrotib, linatinib, etc.); 4. Patients with allergic or hypersensitive constitution or autoimmune diseases; 5. Third interstitial effusion (such as large amounts of pleural and ascites) that cannot be controlled by drainage or other means; 6. Use of steroids for more than 50 days, or long-term use of steroids is required; 7. Radiotherapy within 30 days prior to the first dose of study drug therapy (within 2 weeks, palliative care for peripheral bone metastases and recovery from all toxicity); 8. Uncontrolled symptomatic brain metastases or mental abnormalities that cannot properly represent subjective symptoms; 9. According to the researchers' judgment, the abnormal blood coagulation function is of clinical significance and has bleeding tendency or is receiving thrombolytic or anticoagulant therapy; 10. Receive any other antineoplastic therapy, including antineoplastic Chinese patent medicines and immunopreparations; 11. Residual toxicity (e.g., grade = 2 in the blood system, cardiovascular system or neurotoxicity) is present in previously received treatment. Hair loss is allowed; 12. Inability to swallow, chronic diarrhea, and intestinal obstruction, where there are multiple factors affecting drug administration and absorption; 13. Other malignant tumors (except GC) occurred in the 5 years prior to enrollment, except carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin previously treated for the purpose of radical resection; 14. Pregnant or nursing women who are fertile but refuse to use contraception; 15. A history of serious heart disease or disease, including: a documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina requiring medication, clinically defined valvular disease, a history of severe myocardial infarction, and refractory hypertension; 16. Received allograft/solid organ transplantation. 17. According to the judgment of the researcher, there are serious concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that endanger the safety of patients or affect the completion of the study; 18. Other circumstances that the investigator determined were not appropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS;ORR;AE; | — |
Countries
China
Contacts
Public ContactLiangjun Zhu
Jiangsu Cancer Hospital
Outcome results
None listed