Unresectable or Metastatic Colorectal Cancer
Conditions
Brief summary
To observe and evaluate the efficacy and safety of FOLFOX/FOLFIRI± target-directed regimen containing Levofolinic Acid (Zuoyu ®) in first-line treatment of unresectable or metastatic colorectal cancer
Interventions
DRUGFOLFOX/FOLFIRI
mFOLFOX6 ：oxaliplatin 85mg/m² IV infusion 2h d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); FOLFIRI ：Irinotecan 180mg/m ² static pulse infusion 30min\ 90min d1, 5-FU 400mg/m² push d1, Then 5-FU 1200mg/(m2▪d)×2d+ Levofolinic Acid 200mg/m² continuous mixed infusion for 46-48h (total 5-FU 2400mg/m²); The combination of cetuximab/bevacizumab and other targeted agents depends on the patient.
Sponsors
China Medical University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, ≥18 years old; * Patients with histopathologically confirmed unresectable or metastatic colorectal cancer who have not previously received chemotherapy or targeted therapy for unresectable or metastatic lesions; * Have at least one measurable lesion according to RECIST 1.1 standards; * ECOG PS score: 0-2; * Expected survival greater than 3 months; * Routine blood routine, liver and kidney function, electrocardiogram and other routine tests were basically normal, no contraindications of chemotherapy; * The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up visits; * Researchers believe treatment can benefit.
Exclusion criteria
* A proven allergy to the test drug and/or its excipients; * Pregnant or lactating women; * Patients judged by the investigator to be unsuitable for inclusion in this study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 2 years | The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 2years | The date from random to the first occurrence of disease progression or death from any cause, whichever comes first |
| Disease control rate (DCR) | 2years | The proportion of patients whose BOR is CR, PR, and stable disease (SD) assessed |
Countries
China
Contacts
Primary ContactJingdong Zhang
Backup ContactQian Dong
Outcome results
None listed