Locally advanced right-sided colon cancer
Conditions
Interventions
Experimental group:XELOX+ slulimab combined with bevacizumab
Oxaliplatin: 130 mg/m2, IV, Day 1, q3w.
Capecitabine: 1000 mg/m2. PO, BID, Days 1–14, q3w.
Serplulimab: 300 mg fixed dose, IV, Day 1, q3w.
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. MSS/pMMR right-sided colon adenocarcinoma confirmed by histopathology (cecum, ascending colon, hepatic flexure, right transverse colon); 3. Locally advanced right-sided colon cancer should be classified as T3 or T4 based on abdominal CT assessment; 4. At least one measurable lesion is present according to RECIST 1.1; 5. ECOG score: 0 - 1; 6. Expected survival time: more than 3 months; 7. Adequate organ function: Total bilirubin = 1.5×10^9 /L, platelet count >= 75×10^9 /L, hemoglobin >= 90 g/L, white blood cell >= 3.0×10^9 /L; 8. The female participants agreed to strictly practice contraception; for the male participants whose partners were of childbearing age, they agreed to use effective contraceptive methods during the study period. 9. Voluntarily sign the informed consent form, and be willing and capable of complying with the scheduled visits, research treatments, laboratory tests, and other trial procedures as per the plan.
Exclusion criteria
Exclusion criteria: 1. Has received chemotherapy or biological therapy in the past; 2. The infection is out of control, or the patient has received antibiotic treatment within 72 hours prior to undergoing chemotherapy; 3. Myelodysplastic syndrome or other hematopoietic disorders; 4. Other malignant tumors in this year (excluding carcinoma in situ and basal cell carcinoma); 5. Patients with central nervous system metastasis; 6. Other diseases, such as active tuberculosis, HIV infection, AIDS, hepatitis B (including patients with HBV-DNA 7.5% after the use of hypoglycemic drugs, or uncontrolled hypertension is defined as systolic blood pressure/diastolic blood pressure >140/90 mmHg after the use of antihypertensive drugs. 8. Myocardial infarction, severe/unstable angina pectoris, NYHA III or IV congestive heart failure within the past 12 months. 9. Patients who are allergic to the therapeutic drugs in this study; 10. Suffering from mental or neurological disorders and unable to cooperate; 11. Pregnant or lactating women; Women of childbearing age refuse to accept contraceptive measures; 12. Active autoimmune diseases, with a history of autoimmune diseases, receiving corticosteroids or immunosuppressants, or undergoing hormone replacement therapy (such as thyroid hormone, insulin, etc.). 13. Have received a live vaccine within 30 days (seasonal flu vaccines are allowed as they are inactivated); 14. Have received any other investigational drug treatment or participated in another interventional clinical trial within 30 days after the screening period; Undergo surgery within 30 days (except for diagnostic biopsies, and the surgical incision should be completely healed before the administration of the study drug). Received radiotherapy within 30 days. 15. Other serious medical conditions led the researchers to believe that the patient did not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Major pathological response (MPR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactYan Shi
The First Affiliated Hospital of Army Medical University
Outcome results
None listed