Gastric cancer or colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years male or female; 2. Patients with histologically or cytologically confirmed advanced or metastatic gastric cancer and colorectal cancer; 3. Patients who had previously progressed after receiving standard second-line advanced treatment; 4. Patients with at least one evaluable or measurable lesions as per RECIST version 1.1; (CT scan length and diameter of tumor lesion>=10mm CT scan of lymph node lesion was short diameter>=15mm scan slice thickness 5mm); 5. ECOG performance status (PS) 0 - 2; 6. Life expectancy of at least 3 months; 7. Patients with adequate organ function at the time of enrollment as defined below: (1) Blood routine examination standard (without blood transfusion within 14 days before enrollment): Hb >=90g/L; WBC>=3.0x10^9/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; (2) Biochemical examination shall meet the following standards: BIL 50ml/min (Cockcroft-Gault math); 8. Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period; 9. Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
Exclusion criteria
Exclusion criteria: 1. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years; 2. Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy =140 mmHg and diastolic blood pressure >=90 mmHg) despite treatment with several hypotensive agents; Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollmentPatients with acute coronary syndrome and cardiac dysfunction; 7. Women who are pregnant or breastfeeding; 8. Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease; 9. Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease: included HIV positive or a history of organ transplantation and allogeneic bone marrow transplantation; 10. Patients with interstitial lung disease with symptoms or signs of activity; 11. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterionCoagulation abnormalities (INR>1.5APTT>1.5ULN); 12. Urine protein >= ++ or confirmed 24 hour urine protein concentration; 13. Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture; 14. Patients with a seizure disorder who require pharmacotherapy; 15. Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients; 16. The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request; 17. participated in other clinical studies before and during treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-Free Survival;median Overall Survival; | — |
Countries
China
Contacts
Zhongshan Hospital, Xiamen University