Advanced gastric cancer, advanced colorectal cancer
Conditions
Interventions
Patients with advanced gastric cancer group:teriprizumab combined with low-dose paclitaxel for injection (albumin-bound)
Patients with advanced colorectal cancer group:teriprizumab combined with low-dose paclitaxel for injection (albumin-bound)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years. 2. Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the gastric or gastroesophageal junction or colorectal adenocarcinoma. 3. Subjects with advanced gastric or gastroesophageal junction adenocarcinoma after treatment failure of first-line systemic therapy (which must contain platinum and fluorouracil treatment for no less than 2 cycles, including or without PD-1 antibody, CTLA-4 antibody and other immune checkpoint inhibitors); Or who have previously failed or been intolerant to systemic therapy for recurrent or metastatic colorectal adenocarcinoma, the last systemic therapy (must include fluorouracil, oxaliplatin, and irinotecan, with or without targeted therapy such as bevacizumab and cetuximab, or immune checkpoint inhibitors such as PD-1 antibody and CTLA-4 antibody), the time of disease progression should not exceed 3 months. 4. No radiotherapy or non-targeted focal radiotherapy > 4 weeks after completion (only used outside the site evaluated in this trial). 5. Have at least one measurable lesion (according to RECIST 1.1). Note: Lesions that have previously received radiotherapy cannot be considered as target lesions unless there is definite progression after radiotherapy. 6. ECOG score 0-1. 7. Life expectancy >= 3 months. 8. ALT and AST were less than the upper limit of normal (2.5 times of ULN) (less than 5 times of ULN in patients with liver metastasis). 9. Serum albumin >= 3.0g/dL. 10. Serum alkaline phosphatase is less than 2.5 times of ULN. 11. Total bilirubin = 1500/mm^3, hemoglobin (Hb) > 9g/dl, platelets >100,000/mm^3. 14. Within 21 days prior to enrollment, women of reproductive age must confirm that the serum pregnancy test is negative and consent to use effective contraception during the study drug use period and within 28 days after the last dose. 15. Written informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Microsatellite is highly unstable (MSI-H) or DNA mismatch repair gene expression deletion (dMMR). 2. Subjects with proven/clinical symptoms of brain metastases and/or cancerous meningitis. 3. Received anti-tumor cytotoxic drug therapy, biologic drug therapy (such as monoclonal antibodies), immunotherapy other than immune checkpoint inhibitors (such as interleukin-2 or interferon), or other investigational drug therapy within the first 4 weeks of enrollment. 4. The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Subjects who had vitiligo or had complete remission of asthma in childhood and did not need any intervention as adults were enrolled; Asthma requiring medical intervention with bronchodilators is not included). 5. Subjects with active tuberculosis who were receiving anti-TB therapy or had received anti-TB therapy within 1 year prior to screening. 6. Subjects with comorbidities requiring long-term immunosuppressive drug therapy or systemic or local use of corticosteroids with immunosuppressive doses (doses >10mg/ day of prednisone or other therapeutic hormones). 7. Received any anti-infective vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment. 8. Heart failure, coronary heart disease, and myocardial infarction occurred within 6 months prior to study inclusion. 9. Lactation. 10. Subjects without legal capacity. 11. Other malignancies within 5 years. 12. Known allergy to any drug in the study and its adjuvants. 13. A subject is known to be infected with HIV or is known to be HIV-seropositive. 14. HBsAg positive and HBV DNA copy number positive (quantitative detection >= 1000cps/ml). 15. Positive blood screening for chronic hepatitis C (HCV antibody positive). 16. Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance, or may affect the subject's signing of the informed consent, or may be inappropriate for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Disease control rate;Duration of remission;Safety; | — |
Countries
China
Contacts
Public ContactXu Ruihua
Sun Yat-sen University Cancer Center
Outcome results
None listed