Clinical trial · Interventional
FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
Clinical Study on the Efficacy and Safety of FOLFOX/FOLFIRI± Targeted Drug Regimen Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer
NCT05797883CI-TRIAL-00065286unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable or Metastatic Colorectal Cancer | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX/FOLFIRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOX/FOLFIRI
- description
- q2w, after 8 cycles of medication or patient intolerance or disease progression;
- interventionNames
- Drug: FOLFOX/FOLFIRI
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 2 years
- description
- The proportion of patients whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by iRECIST v1.1
Secondary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.