Colorectal cancer
Conditions
Interventions
Group of colorectal cancer:SBRT+bevacizumab+Envafolimab
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1). Age 18-75 years old, both men and women; 2). Patients with colorectal cancer liver metastases that are inoperably resectable or curable by radiotherapy and chemotherapy confirmed by histological diagnosis, the pathological type is adenocarcinoma or intramucosal adenocarcinoma (patients diagnosed due to superficial materials of some lesions), high risk: CRS = 3 points; 3). Metastases: = 10; 4). The largest lesion is less than or equal to 5cm; 5). Genetic testing diagnosed as microsatellite stable type or pathological diagnosis as mismatch repair function intact type; 6). Failure of second-line therapy or failure of three-drug combined targeted therapy; 7). According to RECIST v1.1 standard baseline assessment includes index lesions and non-index lesion assessment, the total number of baseline index lesions does not exceed 15, the basic criteria for inclusion of index lesions are: not less than 5mm×5mm, and the sum of the maximum cross-sectional area is used as the quantitative evaluation basis. Selection criteria for non-index lesions: those that do not meet the measurement size criteria, those that meet the measurement criteria but exceed the criteria for inclusion in the total number of > (5 measurable lesions) and lesions defined as non-measurable. 8). ECOG within 7 days before the first administration of the study drug: 0~2; 9). Expected survival= 6 months; 10). The function of important organs meets the following requirements: absolute neutrophil count (ANC) =1.5×109/L; Platelets = 100×109/L; Total bilirubin = 1.5 × ULN, ALT and AST = 2.5 × ULN; ALP = 5 × ULN; serum creatinine = 1.5 × ULN or creatinine clearance > 60 mL/min (calculated by the Cockcroft-Gault formula); Activated partial thromboplastin time (APTT), international normalized ratio (INR) and prothrombin time (PT) = 1.5 × ULN; 11). Female subjects of childbearing potential who must have a negative blood pregnancy test within 7 days prior to the first dose, and male subjects whose partners are women of childbearing age, who need to use at least one medically recognized contraceptive method (such as an IUD, birth control pill or condom) during the study treatment; 12). Subjects voluntarily joined the study, signed informed consent, complied well, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1). Patients who have previously received radiotherapy or other local treatment of liver metastases; 2). Patients with gastrointestinal obstruction and inability to feed enteral nutrition by mouth or naso; 3). Patients with systemic inflammatory response syndrome (SIRS) or uncontrolled intestinal infection who are taking broad-spectrum antibiotics; 4). Patients with metastases from other parts of the non-liver; 5). Have a history of active autoimmune diseases and autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except vitiligo or recovered childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune-mediated hypothyroidism treated with stable doses of thyroid-replacement hormones; Type I diabetes mellitus with a stable dose of insulin; 6). Have a history of immunodeficiency, including positive HIV antibody test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 7). The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: (1) heart failure above NYHA grade II (2) unstable angina (3) myocardial infarction within 6 months (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention; 8). The subject has severe pneumonia, bacteremia, infection comorbidities, etc. that require hospitalization; Baseline chest imaging suggests active pulmonary inflammation with clinically relevant symptoms or signs; signs and symptoms of infection present in the first 2 weeks prior to study drug use, or requiring oral or intravenous antibiotic therapy, except for prophylactic antibiotics; 9). Subjects with past and current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, etc. that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; subjects with radiation pneumonitis within 6 months; 10). Subject has known active or suspected autoimmune disease. Admission was allowed to participants who were in a stable state and did not require systemic immunosuppressant therapy; 11). Patients with active tuberculosis infection found by medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment; 12). Pregnant or lactating women; 13). According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) that require combined treatment, serious abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of test data; 14). Failure to complete at least 1 cycle of clinical trial research according to this protocol caused by non-experimental drug factors, safety and efficacy evaluation cannot be carried out; 15). Serious violation of this research protocol, failure to take medication in accordance with the prescribed dose, method and course o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate of disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall lifetime; | — |
Countries
China
Contacts
Public Contactyangzhibin
Yunnan Cancer Hospital
Outcome results
None listed