Metastatic colorectal cancer
Conditions
Interventions
Single arm :Fruquintinib: 5 mg once daily (qd), administered orally on Days 1–14, followed by a 7 day rest period
one cycle every 21 days.
SBRT: Select measurable metastatic lesions in the liver or lung with diameter >2 cm and <5 cm (confirmed by puncture pathology) for radiotherapy.
Prescription dose: 15 Gy in 3
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects with histologically or cytologically confirmed colorectal cancer; 2. Subjects with evidence of Stage IV metastatic disease and measurable baseline lesions according to RECIST 1.1; 3. Tumor tissue testing indicates MSS subtype (by PCR or sequencing); 4. Prior treatment with standard first-line and second-line therapies for advanced colorectal cancer; 5. Age >= 18 years, any gender, ECOG performance status 0–1; 6. Expected survival > 6 months; 7. Subjects must meet the following hematologic criteria:Absolute neutrophil count >= 1.5 × 10^9/L; Hemoglobin >= 10 g/dL; Platelet count >= 100 × 10^9/L 8. Subjects must meet the following biochemical criteria: Total bilirubin = 60 mL/min. 9. Subjects of childbearing potential must use adequate contraceptive measures before enrollment and during the trial; 10. Ability to swallow, retain, and absorb oral medications; 11. Written informed consent has been obtained; 12. Ability to comply with the study protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in another clinical study; 2. Subjects with active bacterial or fungal infection (>= Grade 2, NCI-CTC version 3); 3. Subjects with HIV, HCV, or HBV infection; uncontrolled coronary artery disease or asthma; uncontrolled cerebrovascular disease; or any other disease deemed ineligible by the investigator; 4. Subjects with a current or previous history of other malignancies; 5. Subjects with autoimmune disease or immunodeficiency, or who are receiving immunosuppressive therapy; 6. Pregnant or lactating women. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment; 7. Substance abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study; 8. History of chronic inflammatory bowel disease requiring medical intervention (immunomodulatory, immunosuppressive drugs, or surgery) within <=12 months before randomization; 9. History of hypersensitivity to any of the study drugs or their components; 10. Subjects considered inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactHu Jing
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed