Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC

Prior treatment

• Pregnant (positive pregnancy test before medication) or breastfeeding women;

Other illness

• Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs;
• Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
• History of serious cardiovascular and cerebrovascular diseases;
• Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
• Currently has central nervous system (CNS) metastasis or has a history of unstable or clinically symptomatic brain metastasis;

Lab values

• Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (hepatitis B virus DNA ≥ 1 × 104 copies/mL or\>2000 IU/ml);

Other

• Urine protein ≥ 2+, or 24-hour urine protein \>1.0g;
• Histologically confirmed MSI-H/dMMR tumors;
• Patients deemed unsuitable by the researchers for inclusion in this study.

• Have signed an informed consent;
• 18 to 85 years old (including 18 and 85 years old);
• Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;
• Have not received anti-tumor treatment for metastatic disease;
• Inability to tolerate intensive treatment regimens based on oxaliplatin or irinotecan as determined by researchers;
• At least one measurable lesion;
• Expected life expectancy ≥ 12 weeks;
• The function of important organs within the 14 days prior to enrollment meets the following requirements (no blood components or cell growth factors are allowed to be used within the 14 days prior to enrollment):
• Neutrophil absolute count ≥ 1.5 × 10\^9/L;
• Platelets ≥ 80 × 10\^9/L;
• Hemoglobin ≥ 8g/dL;
• Total bilirubin\<1.5 times ULN;
• ALT and AST\<2.5 times ULN (liver metastasis patients\<5 times ULN);
• Serum creatinine ≤ 1.5 times ULN;
• Endogenous creatinine clearance rate\>50ml/min;
• International standardized ratio (INR) of coagulation function ≤ 1.5 × ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
• Women of childbearing age or men whose partners have a desire to conceive should take effective contraceptive measures.