FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
Phase 2
Recruiting
- Conditions
- Unresectable or Metastatic Colorectal Cancer
- Interventions
- Drug: FOLFOX/FOLFIRI
- Registration Number
- NCT05797883
- Lead Sponsor
- China Medical University, China
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FOLFOX/FOLFIRI FOLFOX/FOLFIRI q2w, after 8 cycles of medication or patient intolerance or disease progression;
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China