Colon cancer
Conditions
Interventions
Experimental group:PD-1 monoclonal antibody combined with angiogenesis drugs
Sponsors
First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Join the group voluntarily and sign written informed consent; 2. Aged >= 18 years; 3. Recurrent or metastatic colon cancer confirmed by histology or cytology; 4. Progress after receiving 1-line system therapy; 5. According to the solid tumor efficacy evaluation criteria (RECIST Version 1.1), there was at least one radiographically measurable lesion. Lesions located in the previous radiation field can be regarded as measurable lesions if progression is confirmed; 6. The physical status (PS) score of ECOG was 0~1; 7. If the major organs are functioning normally, the following criteria are met: (1) Hemoglobin >=90 g/L; (2) Absolute neutrophil count (ANC) >=1.5x10^9/L; (3) Platelet count >=100x10^9/L; (4) Albumin >=28 g/L; (5) Total bilirubin <=1.5x upper limit of normal value (ULN); (6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5xULN (ALT or AST <=5xULN for subjects with liver metastasis); (7) Creatinine <=1.5xULN; (8) International Normalized ratio (INR) or prothrombin time (PT) <=1.5xULN; (9) Activated partial thromboplastin time (APTT) <=1.5xULN; (10) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range; (11) Myocardial enzyme profiles were within the normal range (simple laboratory abnormalities that were not clinically significant were also allowed to be included).
Exclusion criteria
Exclusion criteria: 1. Prior to the administration of the drug in the first study, one of the following conditions was met: (1) >=30% of bone marrow had received radiotherapy within 14 days prior to treatment; (2) Received radiotherapy for lung lesions within 6 weeks prior to treatment with a dose of >30Gy (enrolled subjects must recover from toxicity of previous radiotherapy to grade 1 or below, need no glucocorticoid therapy and have no history of radiation pneumonia); (3) The end time of palliative radiotherapy was within 7 days before the first study drug administration; 2. Other malignancies within 5 years, unless the patient has received potentially curable therapy and has no evidence of the disease within 5 years, but this time requirement (i.e. 5 years) does not apply to patients who have successfully undergone surgical excision for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ or other carcinoma in situ; 3. Patients with contraindications to other anti-vascular targeting drugs or PD-1 monoabutances; 4. Other: (1) Received clinical trials of other drugs or medical devices within 4 weeks before enrollment; (2) Failure to follow the study protocol for treatment or follow-up; (3) Anyone who is considered not to be included by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Adverse events; | — |
Countries
China
Contacts
Public ContactZhang Hongmei
First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed