Colorectal Cancer
Conditions
Interventions
Case series:Sintilimab and Regorafenib plus Stereotactic Radiotherapy
Sponsors
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with colorectal adenocarcinoma of p-mmr type confirmed by pathology (histology or cytology), the results of tumor immunohistochemistry were: MLH1 +, MSH2 +, MSH6 +, PMS2 +; 2. Subjects who have received two or more standard chemotherapy schemes, and the scheme drugs include oxaliplatin, irinotecan and fluorouracil; 3. Aged 18-75 years old; 4. ECoG score is 0-1; 5. Blood routine test and liver and kidney function meet the following conditions: neutrophil count > 1.5 * 109 / L, hemoglobin concentration > 90g / L, platelet count > 80 * 109 / L, ALT and AST 3 months; 7. Patients with at least one tumor focus meeting the criteria of SBRT; 8. Patients who have at least one tumor focus without radiotherapy and are measurable according to the RECIST 1.1 standard; 9. Patients willing to receive long-term follow-up, provide tumor tissue samples, and provide blood samples before and after treatment; 10. Patients willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to the test drug; 2. Patients who have previously received PD-1 / PD-L1 treatment; 3. Patients with active infection requiring systemic treatment; 4. Patients diagnosed as immune deficiency or undergoing systemic steroid therapy; 5. Patients with active autoimmune diseases who need systemic treatment in the past two years (using immunomodulators, corticosteroids or immunosuppressive drugs); 6. Patients with known mental illness or drug abuse disorder that may interfere with the trial; 7. Pregnant and lactating patients; 8. Patients with poor compliance.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Obejective response rate, ORR;Duration of Response, DOR;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactChunxia Du
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed