Colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients with recurrence after colorectal cancer resection or patients with advanced colorectal cancer who have not received any treatment before; 3. ECOG PS score 0-1 points; 4. Estimated survival period >=12 months; 5. The main organ functions are normal, and there are no patients with severe blood, heart, lung, liver, kidney, bone marrow and other dysfunctions and immunodeficiency. The laboratory inspection meets the following requirements: (1) Hemoglobin (Hb) >=90 g/L; (2) White blood cell (WBC) >=3.0x10^9/L; Neutrophil count (NEUT) >=1.5x10^9/L; (3) Platelets (PLT) >=100x10^9/L; (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <=2.5 ULN; renal function (serum creatinine sCr) level <=1.5 ULN; (5) Total bilirubin (TBIL) <=1.5 ULN; (6) Urine protein, urine occult blood <2+; fecal occult blood <2+; 6. Patients voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up; 7. The investigator believes that the treatment can benefit.
Exclusion criteria
Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Suffer from any active autoimmune disease or history of autoimmune disease; 4. Suffer from congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >=500 IU/mL), hepatitis C (hepatitis C antibody positive, and high HCV-RNA (Under the detection limit of the analytical method) or co-infection with hepatitis B and C; or a history of organ transplantation; 5. Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction within 1 year; 6. Pregnant or lactating subjects; 7. According to the judgment of the investigator, subjects who are not suitable for inclusion in this study; 8. Those who have medical systemic diseases and psychiatric diseases that are not suitable for chemotherapy; 9. Those who have acute infection and need antibiotic treatment; 10. Subjects who have participated in other drug clinical trials within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Anhui Medical University