Colorectal cancer
Conditions
Interventions
Treatment group:Atezolizumab in combination with antiangiogenic drugs (bevacizumab/fotumumab/regorafenib and/or chemotherapy (XELOX/mXELIRI/capecitabine/tigatinib) for treatment
Sponsors
Qingdao Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed advanced metastatic colorectal adenocarcinoma with microsatellite stability (MSS) or a pathological complete response (pMMR); 2) Disease progression after previous first-line standard therapy (two-drug chemotherapy in combination with targeted agents); 3 Age >= 18 years, gender not limited; 4) Estimated survival >= 3 months; 5) ECOG score of 0-1; ) At least 1 measurable target lesion according to RECIST1.1 criteria; 7) Good function of major organs, that is, the relevant examination indicators before enrollment the following requirements within 14 days before inclusion: i. Hemoglobin >= 90g/L (no blood transfusion within 14 days);rophil count >= 1.5×10^9/L; Platelet count >= 80×10^9/L; ii. Total bilirin = 60ml/min (Cockcroft-Gault formula). 8) Echocardiography evaluation: left ventricular ejection fraction (LVEF >= 50%; 9) For eligible patients, agree to use a medically approved method of contraception during the period of study treatment and for 6 months after the of study treatment; female patients must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breastfeeding; 10) Sign the informed and have good compliance
Exclusion criteria
Exclusion criteria: 1) The patient is currently participating in other drug clinical trials (non-interventional clinical trials are excluded); 2 Previous or concurrent malignant tumors, except for basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, and cervical or breast in situ cancer that been cured; 3) Patients with known central nervous system metastases. For patients with clinical suspicion of central nervous system metastases, a CT or MRI examination must be performed within28 days before the start of treatment to rule out central nervous system metastases; 4) Pleural effusion or ascites with clinical symptoms requiring clinical intervention; 5 The patient is currently using immunosuppressants for any reason, or is receiving systemic hormone therapy for the purpose of immunosuppression (dose > 1 mg/day prednisone or other equivalent efficacy hormones); 6) The patient has any active autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis); 7) The patient has a history organ transplantation; 8) Comorbid with the following diseases: a) Suffering from hyperthyroidism; b) Suffering from vitiligo;c) History of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and history of chronic diarrhea diseases such as irritable bowel syndrome; d History of sarcoidosis or tuberculosis; e) History of active hepatitis B, hepatitis C, and HIV infection; f) New diagnosis of ana pectoris within 3 months before screening or a myocardial infarction event within 6 months before screening; long-term use of antiarrhythmic is required for arrhythmia (including QTcF: male >= 450ms, female >= 470ms) and New York Heart Association >= II heart failure; g) Asthma requiring medical intervention with bronchodilators (asthma that has completely resolved in childhood and does not require any intervention adults can be included); h) Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other pulmonary inflammatory diseases that require the of glucocorticoids; i) Patients with a history of substance abuse of psychiatric drugs and cannot quit or have mental disorders. 9) Urinalysis suggests urine >= 2 and 24-hour urine protein quantitative > 1.0g; 10) There are other situations that are not suitable for in the group according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactCao Yufeng
Qingdao Traditional Chinese Medicine Hospital
Outcome results
None listed