Rectal cancer
Conditions
Interventions
Experimental group:SBRT+ Iparomlimab and Tuvonralimab Injection +TAS-102 + oxaliplatin
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Patients with histologically confirmed T3-4/N M0 rectal adenocarcinoma; 3. Have not received anti-tumor therapy in the past; 4.ECOG:0~1; 5. The lower edge of the tumor is = 12 weeks; 7. The function of major organs is normal, that is, the following criteria are met: (1) Routine blood examination: a.HB >= 90g/L; b.ANC >= 1.5×10^9/L; c.PLT >= 80×10^9/L; (2) Biochemical examination: a.ALB >= 30g/L; b. ALT and AST = 60ml/min; 8. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= lower limit of normal (50%); 9. Subjects of childbearing potential should be patients who agree to use contraception for the duration of the study and for 6 months after the end of the study; 10. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patient has any active autoimmune disease or has a history of autoimmune disease; 2. Patients are using immunosuppressants, or systemic hormone therapy to achieve immunosuppressive purposes (dose> 10mg/day prednisone or other efficacy hormones) and continue to use them within 2 weeks prior to enrollment; 3. Patients with any severe and/uncontrolled disease, including: patients with suboptimal blood pressure control (systolic blood pressure > = 170mmHg or diastolic blood pressure > = 100 mmHg); Grade I myocardial ischemia or myocardial infarction, arrhythmias (including QT interval >= 480ms), and grade I cardiac insufficiency; 4. Active or uncontrolled severe infection; 5. Pregnant or lactating women; 6. Patients with other malignancies within 5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix that have been cured); 7. Patients who have participated in clinical trials of other drugs within four weeks; 8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigator; 9. Those who are considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;R0 resection rate;Major Pathological response;Tumor regression grade;Anus preserving rate; | — |
Countries
China
Contacts
Public ContactWang Guixian/Sun Zhenqiang
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed