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FOLFOX/FOLFIRI Containing Levofolinic Acid (Zuoyu ®) in the Treatment of Unresectable or Metastatic Colorectal Cancer

C

China Medical University, China

Status and phase

Enrolling
Phase 2

Conditions

Unresectable or Metastatic Colorectal Cancer

Treatments

Drug: FOLFOX/FOLFIRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05797883
HL-ZY-002

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

FOLFOX/FOLFIRI
Experimental group
Description:
q2w, after 8 cycles of medication or patient intolerance or disease progression;
Treatment:
Drug: FOLFOX/FOLFIRI

Trial contacts and locations

1

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Central trial contact

Jingdong Zhang; Qian Dong

Data sourced from clinicaltrials.gov

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