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. Sign a written informed consent before implementing any trial-related procedures. 2. Male or female, aged >=18 and 6 months. 8. Sufficient organ function. Subjects need to meet the following laboratory indicators: Absolute neutrophil count (ANC) >= 1.5 x 109/L without using granulocyte colony-stimulating factor in the recent 14 days; Platelets >= 100 × 109/L without blood transfusion in the recent 14 days; Hemoglobin > 9g/dL without blood transfusion or using erythropoietin in the recent 14 days; Total bilirubin = 60 ml/min; Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. 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; Myocardial enzyme spectrum within the normal range (subjects with simple laboratory abnormalities judged as clinically insignificant by the investigator are also allowed to enroll). 9.For female subjects of childbearing age, a urine or serum pregnancy test should be performed and the result should be negative within 3 days before receiving the first administration of the study drug (Day 1 of Cycle 1). If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age female is defined as at least 1 year after menopause, or having undergone surgical sterilization or hysterectomy. 10. If there is a risk of conception, all subjects (both male and female) need to adopt contraceptive measures with an annual failure rate less than 1% during the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1. Known to have squamous cell carcinoma, undifferentiated carcinoma or other histological types of colorectal cancer, or colorectal cancer with adenocarcinoma mixed with other histological types. 2. Diagnosed with other malignant diseases other than colorectal cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has been radically treated, and/or carcinoma in situ that has been radically resected). 3. Known to have signs of active bleeding in the lesion shown under endoscopy. 4. Currently participating in an interventional clinical study treatment, or having received other study drugs or used study devices for treatment within 4 weeks before the first administration. 5. Subjects who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy or any treatment targeting the mechanism of tumor immunity. 6. Received systemic treatment with traditional Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration. 7. Had an active autoimmune disease requiring systemic treatment (such as using disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Replacement therapies (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered as systemic treatment. 8. Receiving systemic glucocorticoid treatment (excluding nasal, inhaled or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study drug; Note: The use of physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs) is allowed. 9. Known to have undergone allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 10. Known to be allergic to the drugs used in this study. 11. Having multiple factors affecting capecitabine (such as inability to swallow and intestinal obstruction, etc.). 12. Before starting treatment, not fully recovered from the toxicity and/or complications caused by any intervention (i.e., <= grade 1 or reaching the baseline, excluding fatigue or alopecia). 13. Known to have a history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies). 14. Untreated active hepatitis B (defined as positive for HBsAg and detection of HBV-DNA copy number greater than the upper limit of the normal value in the laboratory of the research center); Note: Hepatitis B subjects meeting the following criteria can also be enrolled: HBV viral load < 1000 copies/ml (200 IU/ml) before the first administration. Subjects should receive anti-HBV treatment during the entire chemotherapy drug treatment period of the study to avoid viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), they do not need to receive preventive anti-HBV treatment, but need to closely monitor viral reactivation. 15. Subjects with active HCV infection (positive for HCV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete remission(pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate,DCR;Disease free survival(DFS);R0 resection rate;Safety; | — |
Countries
China
Contacts
Public ContactHaipeng Liu
The second hospital of Lanzhou University
Outcome results
None listed