SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC

Prior treatment

• Patients with serious, uncontrolled, concurrent infection(s).
• Significant weight loss (\>10%) in the prior 3 months.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.

Other illness

• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.

Other

• Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
• Patients with more than 5 discrete metastatic lesions.
• Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study

• Patients must have biopsy proven unresectable MCRC.
• Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.
• Age ≥ 18 years
• Patients must have measurable disease at baseline.
• Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
• Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
• Patients must have a Karnofsky Performance Scores (KPS) \>60 8. Aspartate aminotransferase, alanine aminotransferase \& Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.
  • 9\. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should have a negative pregnancy test. 12. Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.
  • 13\. Patients must provide verbal and written informed consent to participate in the study.
  • 14\. Total bilirubin: within normal institutional limits