colon cancer
Conditions
Interventions
Single arm:PD-1+Apatinib+Chemotherapy
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histologically confirmed colon cancer (cT4N0-2M0) without distant metastasis (AJCC 8th); 3. ECOG 0-1; 4. Surgical treatment is planned after completion of neoadjuvant therapy; 5. Right colon cancer (including ileocecal area, ascending colon, transverse colon to splenic flexion); 6. Patients can swallow pills normally; 7. Expected overall survival >=12 months; 8. Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts >3000/ul; Absolute neutrophil count (ANC) >=1500 cells/ul; Platelet count >=100,000/ul; Hemoglobin >=9.0 g/dL; 9. AST, ALT and alkaline phosphatase <=2.5 ULN; Serum bilirubin <=1.5 ULN; creatinine<ULN; 10. Prothrombin time (PT), international standard ratio (INR) <=1.5 ULN; 11. Patients who have not received systemic chemotherapy or immunotherapy; 12. Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment; 13. Informed consent has been signed.
Exclusion criteria
Exclusion criteria: 1. Patients have received any prior systemic antitumor therapy; 2. Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study); 3. Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed; 4. Certain or suspected distant metastases; 5. The patient has a history of autoimmune disease; 6. Serious uncontrolled systemic diseases, such as severe active infections; 7. A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive; 8. Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin; 9. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA >500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA =140 mmHg or diastolic >=90 mmHg); 15. Urine routine indicated urinary protein >=++ and confirmed 24-hour urinary protein >1.0g; 16. Known to be allergic to any study drug; 17. Patients have participated in other drug clinical studies within 4 weeks before enrollment; 18. Lactating women; 19. According to the judgment of the researcher, the patient may have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response; | — |
Countries
China
Contacts
Public ContactWeijia Fang, Xiangming XU
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed