Rectal cancer
Conditions
Interventions
test group:Sintilimab 200 mg ivgtt, Q3W, Anlotinib 8 mg PO QD D1-14 and chemotherapy XELOX for 6 cycles
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 70 years old; both male and female; 2. Middle-low rectal adenocarcinoma (less than 10cm from the anal verge) confirmed by histopathology, clinical stage is cT3/T4 or cN+, M0; 3. Tissue samples must be provided for biomarker analysis, and newly obtained tissue is preferred. Patients who cannot provide newly obtained tissue can provide 5-8 5um-thick paraffin sections that are archived and preserved; tumor tissue immunohistochemistry (IHC) is determined as pMMR or determined as MSS by NGS sequencing/PCR capillary electrophoresis; 4. No bleeding, perforation, obstruction, etc. in urgent need of surgery; 5. ECOG score: 0-1 points; 6. Have not undergone any anti-tumor treatment; 7. Expected survival more than 5 years (except for the tumor itself); 8. The main organs are functioning normally, that is, the following criteria are met: (1) Blood routine examination: HB>=90 g/L; (without blood transfusion within 14 days) ANC>=1.5x10^9/L; PLT >=75x10^9/L; (2) Biochemical tests: ALB>=30g/L; (without ALB infusion within 14 days) ALT and AST=60ml/min; 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >=lower limit of normal (50%); 10. The subjects voluntarily joined the study, signed the informed consent, and were able to comply with the visits and related procedures specified in the protocol; 11. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures during the entire treatment period and 6 months of treatment.
Exclusion criteria
Exclusion criteria: 1. Allergy to anlotinib hydrochloride and/or its excipients and sintilimab has been confirmed; 2. There are multiple factors that affect the absorption of oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. The use of immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal, inhaled or other local glucocorticoids or systemic glucocorticoids at physiological doses (ie not more than 10 mg/day) prednisone or equivalent doses of other glucocorticoids); 4. Received pelvic radiotherapy in the past; 5. Active, known or suspected autoimmune disease or history of the disease within the past 2 years (Vitiligo, psoriasis, alopecia or Grave's disease not requiring systemic treatment within the past 2 years, only thyroid Hypothyroidism on hormone replacement therapy and type 1 diabetes patients requiring only insulin replacement therapy can be enrolled); 6. Any one within 6 months prior to the start of treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class II-IV) , cerebrovascular events, transient ischemic attacks, severe arrhythmias requiring medical treatment, or symptomatic pulmonary embolism; 7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 8. Uncontrolled concurrent diseases include but are not limited to: HIV-infected persons (HIV antibody positive). Serious infections that are active or poorly clinically controlled; 9. Pregnant or lactating women; 10. Patients with other malignant tumors within 5 years (except for basal cell carcinoma of the skin and carcinoma in situ of the cervix); 11. Those with a history of psychotropic substance abuse and unable to quit or those with mental disorders; 12. Patients who have participated in clinical trials of other drugs within 4 weeks; 13. Known acute or chronic active hepatitis B (HBsAg positive and HBV DNA >=200 IU/mL or >=103 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive); 14. Within 4 weeks before the first dose of study treatment or planning to receive live attenuated vaccine during the study; 15. Received major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first dose of study treatment; 16. Significant malnutrition, such as the need for intravenous nutritional supplementation; except for malnutrition corrected for more than 4 weeks before the first dose of study treatment; 17. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and/or uncertainty in survival assessment; 18. History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea; 19. Any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months prior to enrollment; 20. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (implantable venous port or catheter-derived thrombosis, or superficial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Complete Response Rate;Objective response rate;Major Pathologic Response Rate;Disease-free survival Rate;Safety;Local recurrence free survival rate;Anal retention rate;Overall Survival Rate;Quality of life score;Surgical complication rate; | — |
Countries
China
Contacts
Public ContactZong Hong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed