Colorectal Cancer
Conditions
Sponsors
Naval Hospital No. 971 of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, age 18-75 years old; 2. Confirmed colorectal cancer by histopathological pathology, and cannot be surgically resected; 3. For patients who have failed first-line therapy, the definition of treatment failure: disease progression or toxic side effects are intolerable during or after first-line systemic chemotherapy; For neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months of discontinuation of therapy, it should be counted as first-line treatment failure; 4. At least one measurable lesion according to RECIST1.1 criteria; 5. ECOGPS score: 0-2 points; 6. Estimated survival greater than 3 months; 7. Patients with normal function of major organs and no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities, and laboratory tests meet the following requirements: (1) Hemoglobin (Hb) >=90g/L; (2) White blood cell (WBC) >=3.0×10^9/L; neutrophil count (NEUT) >= 1.5×10^9/L; (3) Platelets (PLT) >= 100×10^9/L; (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <= 2.5 times the upper limit of normal (ULN), and renal function (serum creatinine sCr) level <= 1.5 times the upper limit of normal (ULN); (5) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN). 8. Subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up; 9. The investigator believes that the treatment can be beneficial.
Exclusion criteria
Exclusion criteria: 1. Those who have confirmed allergy to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 3. Pregnant or lactating women; 4. Patients who are judged by the investigator to be not suitable for inclusion in this study; 5. Patients with internal and systemic diseases and psychiatric diseases that are not suitable for chemotherapy; 6. Patients who have participated in clinical trials of other drugs within four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR,Disease control rate;PFS,Progression-free survival;AE,Adverse events; | — |
Countries
China
Contacts
Public ContactHou Xiaowei
Naval Hospital No. 971 of the Chinese People's Liberation Army
Outcome results
None listed