Oral Chemotherapy, Targeted Therapy and Immunotherapy With/Without Radiotherapy as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer
Trial Parameters
Brief Summary
The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. patients with advanced colorectal adenocarcinoma of MSS/pMMR confirmed by histologic or cytologic diagnosis; 2. aged 18 years and older; 3. have a quality of life score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG); 4. can take oral medications; 5. expected survival ≥ 3 months; 6. progressed after standard second-line or more than second-line therapy (received oxaliplatin, irinotecan, and fluorouracil analogs); 7. have a measurable target lesion according to RECIST v1.1 evaluation criteria; 8. have a number of recurrent metastatic organs ≤ 2 for all measurable lesions, a maximum diameter of recurrent metastatic lesions ≤ 5 cm, and a total number of recurrent metastatic lesions ≤ 10; 9. agree to provide previously stored tumor tissue specimens or perform biopsies to collect tumor lesion tissue for biomarker analysis 10. have chest, abdomen and pelvis CT or whole body PET-CT results within 4 weeks before enrollment; 11. no ascites; 12. having ad