colorectal cancer
Conditions
Interventions
Observation group (Fruquintinib combined with XELOX and PD-1 inhibitor):None
Sponsors
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; 2. Aged 18-75 years old (including 18 and 75 years old) 3. male or female; 4. Histologically or cytologically confirmed potentially resectable advanced colorectal cancer (AJCC 8th T4bNanyM0 or Tany NanyM1). The primary tumors is in the right-sided,or in the left-sided but with RAS/ BRAF-mutated. 5. Patients had received at least one cycle of Fruquintinib combined with XELOX and PD-1 inhibitor for conversion therapy. 6. No other systematic treatment before conversion therapy with Fruquintinib combined with XELOX and PD-1 inhibitor. 7. At least one measurable lesion was required. (Response evaluation criteria in Solid Tumors, RECIST, version 1.1) 8. Imaging assessments were performed at the first assessment cycle. 9. ECOG performance status: 0-1; 10. Expected survival =12 weeks; 11. The main organs and bone marrow functions are basically normal. 12. Female patients of childbearing age or male patients whose sexual partners are female patients of childbearing age: consent to use a medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Participants have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix. Participants had a second primary malignancy detected at enrollment. 2. Concomitant treatment with other antineoplastic agents during this study regimen. 3. Any clinical or laboratory abnormality or bad adherence that the investigator deemed inappropriate for the study. 4. Significant bleeding tendency, severe hepatic and renal insufficiency, and contraindications for immune checkpoint inhibitors before receiving the study regimen. 5. Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality that could increase the study risk or interfere with this study interpretation or that investigator judged ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Countries
China
Contacts
Public ContactGuihua Wang
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Outcome results
None listed