colorectal cancer
Conditions
Interventions
Test group:Brachytherapy and PD-1 inhibitors
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ?Age 18 to 75 years old, male or female; ?Patients with advanced colorectal cancer confirmed by pathological histological biopsy and imaging confirmed metastasis; ?Patients who are in stage IV inoperable or unwilling to operate according to colorectal cancer staging (AJCC); ?Patients must have documented imaging progression; ?There is one metastasis amenable to brachytherapy and at least one measurable lesion in a non-radiotherapy area (based on solid tumor efficacy evaluation criteria(RECIST) 1.1); ?ECOG score 0-1; ? Expected survival of more than 3 months; ?The following laboratory tests performed within 7 days before the first dose of the drug, confirming that the patient's bone marrow, liver and kidney functions meet the requirements for study participation: Hb = 80 g/L (which can be maintained or exceeded by blood transfusion); WBC= 2.5 × 109/L along with ANC = 1.5 ×109/L; PLT = 100 ×109/L; TB=2×ULN;ALT/AST/ALP=2.5×ULN(Liver metastasis patients=5×ULN);Kidney function is within normal limits:CCr> 60 ml/min.Calculation formula: CCr=(140-age)×weight(kg)/[72×Scr(mg/dl)] or CCr=[(140-age)×weight(kg)]/[0.818×Scr(umol/L)]; International normalized ratio (INR) of prothrombin time = 1.5 in patients not previously treated with anticoagulation, prothrombin time (PT) or partial thromboplastin time (APTT) =1.5×ULN,If the subject is on anticoagulation therapy, as long as the PT is within the range prescribed by the anticoagulant; ? Women of childbearing age should have a negative urine and serum HCG test within 7 days prior to the start of treatment; female patients of appropriate age must use a reliable method of contraception before entering the trial and during the study until 30 days after stopping the drug; ? Patients and their families can communicate well, voluntarily participate in this trial, sign a written informed consent, and adhere to and follow the protocol requirements for this trial.
Exclusion criteria
Exclusion criteria: ?Combination of primary malignant tumors from other sites; ?Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris beginning within the last 3 months, congestive heart failure (= New York Heart Association class II), heart machine infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease; ?Patients with comorbid uncontrolled neuropathy (grade 2 or higher) or psychiatric disease; active, known or suspected autoimmune disease; subjects with the following conditions may be enrolled: vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis; ?Those who have failed or progressed after previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell costimulation or checkpoint pathway); ?active tuberculosis considered by chest X-ray, sputum examination, and nucleic acid-PCR; history of treatment for active tuberculosis within 1 year ?Patients with AIDS, other immunocompromised patients (e.g. organ or bone marrow transplantation, long-term glucocorticoid use); ?Pregnant or lactating women; ?Patients who have undergone major surgery or suffered severe trauma within 2 months prior to the first dose; ?Other conditions that the investigator's comprehensive assessment deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and effectiveness of treatment options;PFS;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR; | — |
Countries
China
Contacts
Public ContactQinglian Wen
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed