Microsatellite stable metastatic colorectal cancer
Conditions
Interventions
Experimental group:Radiotherapy combined with regorafenib and PD-1 monoclonal antibody
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Pathologically diagnosed with colorectal adenocarcinoma, confirmed as MSS/pMMR by immunohistochemistry or PCR; 3. Progression after at least 2 lines of standard treatment, or intolerant to standard treatment regimens, metastatic lesions not suitable for surgical or interventional treatment; 4. Metastatic colorectal cancer, stage IV, with at least one liver metastatic lesion, or simultaneous metastasis to liver, abdominal lymph nodes, and lungs; 5. According to RECIST 1.1 criteria, at baseline, at least one liver metastatic lesion suitable for radiotherapy, and another metastatic lesion not receiving radiation can be either a liver metastatic lesion or an extrahepatic metastatic lesion, used for efficacy assessment; 6. If prior radiotherapy was received, it must have been at least 12 weeks since completion; 7. Previous treatment with other targeted therapies is allowed, but must not have received regorafenib treatment or immune checkpoint inhibitor treatment; 8. Adequate bone marrow, liver, and kidney function: Hemoglobin >= 90 g/L, white blood cell count >= 3.0 × 10^9/L, neutrophils >= 1.5 × 10^9/L, platelets >=50 × 10^9/L, serum total bilirubin <= 2 times the upper limit of normal, serum AST and ALT <= 5 times the upper limit of normal, serum creatinine <= 1.5 times the upper limit of normal, or creatinine clearance of 40 mL/min (calculated using the Cockcroft-Gault formula), prothrombin time: international normalized ratio <= 2.3, or prothrombin time extension <= 6 seconds, urine protein < 2+, or 24-hour urine protein quantification < 1.0 g; 9. ECOG score of 0 or 1; 10. Expected survival of more than 3 months; 11. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and must use effective contraception during treatment, male subjects of childbearing potential must also use effective contraception; 12. Subjects must voluntarily participate and demonstrate good compliance, signing a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled pleural effusion, pericardial effusion, or ascites; 2. History of other malignancies within the past 5 years, except for early-stage tumors that have been completely resected; 3. Active or previously recorded autoimmune diseases, such as inflammatory bowel disease (ulcerative colitis, Crohn's disease), systemic lupus erythematosus, rheumatoid arthritis, Graves' disease, etc. 4. Active infections, such as pulmonary tuberculosis, HIV 1/2 antibody positive, syphilis; 5. Co-infection with two types of hepatitis viruses, such as HBV co-infected with HCV, HBV co-infected with HDV; 6. Use of corticosteroids or other immunosuppressants within 14 days prior to PD-1 monoclonal antibody administration; 7. Presence of severe cardiovascular diseases, including difficult-to-control hypertension (based on the average of three measurements, systolic blood pressure >=150 mmHg, or diastolic blood pressure >=100 mmHg), history of hypertensive crisis or hypertensive encephalopathy, unstable angina, congestive heart failure classified as New York Heart Association (NYHA) class II or higher, poorly controlled arrhythmias; 8. Occurrence of thrombosis or embolic events within the 6 months prior to enrollment; 9. Known history of allergy to any component of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;The patient reported symptoms and quality of life;Time to tumor remission, TTR;Duration of Response, DoR;Disease control rate, DCR;Overall survival, OS;Adverse events;Time to tumor progression, TTP; | — |
Countries
China
Contacts
Public ContactLi Jianjun
The First Affiliated Hospital of Army Medical University
Outcome results
None listed