Colorectal cancer
Conditions
Interventions
Experimental group:Irinotecan liposome, 70mg/m2, every 2 weeks (Q2W)
Capecitabine, 1000mg/m2, taken orally, twice a day, from day 1 to day 7, every 2 weeks (Q2W)
Bevacizumab, 5mg/kg, every 2 weeks (Q2W), given by intravenous infusion (In principle, bevacizumab should be used. However, in case of contraindications such as uncontrolled hypertension, arterial or
Sponsors
The Affiliated Hospital of Fudan University, Hua Shan
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Age >= 70 years old; (2) Confirmed by histological examination as the second-line population of metastatic colorectal cancer, who received oxaliplatin treatment in the first-line (MSS or MSI-L/pMMR); (3) Have not received irinotecan or irinotecan liposome treatment previously; (4) According to the RECIST v1.1 criteria, there is at least one measurable or evaluable lesion; (5) ECOG performance status score is 0 to 1; (6) Good bone marrow and organ function: 1) Absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count (PLT) >= 80×10^9/L, hemoglobin (Hb) >= 90g/L, white blood cell count (WBC) >= 3.0×10^9/L, albumin (ALB) >= 32 g/L, and no bleeding tendency; 2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) are all = 60 ml/min (calculated according to the Cockroft-Gault formula); (7) Expected survival period >= 3 months; (8) Be able to understand the situation of this study, and the patient and/or legal representative voluntarily agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1) Patients who are allergic to the study drugs and their excipients; (2) Known or suspected central nervous system metastases; (3) Unable to discontinue the use of, or have not discontinued the use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 2 weeks before enrollment (anticonvulsants [phenytoin, phenobarbital or carbamazepine], rifampicin, rifabutin, St. John's Wort, grapefruit juice, clarithromycin, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole, atazanavir, gemfibrozil, indinavir, etc.); (4) Presence of symptoms and signs of intestinal obstruction; (5) History of other malignant tumors within the past 5 years or currently having other malignant tumors, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer; (6) Patients who are considered by the investigator to be unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DoR;PFS;OS; | — |
Countries
China
Contacts
Public ContactXiaohua Liang
The Affiliated Hospital of Fudan University, Hua Shan
Outcome results
None listed