Colorectal cancer
Conditions
Sponsors
The second hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Male or female, age >=18 years and 6 months; 8. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) was >=1.5x109/L; 2) In the case of no blood transfusion in the past 14 days, platelet >=100×10^9/L; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4) total bilirubin =60ml/min; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 9. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic agent).
Exclusion criteria
Exclusion criteria: 1. Colorectal cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other tissue types, or colorectal cancer with adenocarcinoma mixed with other tissue types; 2. Medium and low rectal cancer (the lower edge of the tumor is less than 10cm away from the dentate line); 3. Presence of unresectable factors, including unresectable due to tumor causes or contraindications to surgery or subject refusal of surgery; 4. Diagnosis of other malignant diseases other than colorectal cancer within 5 years before the first dose (excluding radically cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 5. Known signs of active bleeding of the lesion under endoscopy; 6. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 7. Subjects who have received immunotherapy in the past, including immune checkpoint inhibitors (such as: anti-PD-1/L1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG3 antibody, etc.), immune checkpoint agonists (such as: ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy and any other treatment against the mechanism of action of tumor immunity; 8. Received systemic therapy with anti-tumor indications or immunomodulatory drugs (including thymus peptide, interferon, interleukin, except for topical use for the control of pleural effusion) within 2 weeks before the first dose; 9. Active autoimmune disease requiring systemic therapy (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 10. Systemic glucocorticoid therapy (excluding nasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiologic doses of glucocorticoids (<=10mg/day of prednisone or equivalent) are allowed; 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Known allergies to the drugs used in this study; 13. Patients with multiple factors that affect capecitabine (such as inability to swallow and intestinal obstruction, etc.); 14. Have not recovered adequately from toxicity and/or complications caused by any intervention prior to initiation of treatment (i.e., <=Grade 1 or at baseline, excluding fatigue or alopecia); 15. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive); 16. Untreated active hepatitis B (defined as HBsAg positive and detected HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment period to avoid viral reactivation; 2) for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral loads (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored; 17. Subjects with active HCV infection (HCV antibody posi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate,DCR;Disease free survival,DFS;Event Free Survival, EFS;Pathologic complete remission(pCR);R0 resection rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactHaipeng Liu
The second hospital of Lanzhou University
Outcome results
None listed