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Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

NCT06210360 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-01-18

No results posted yet for this study

Summary

This multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy + surgery + adjuvant chemotherapy or surgery + adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.

Conditions

Interventions

DRUG

Irinotecan liposome injection

50 mg/m² on Day 1 of a 14 day cycle

DRUG

Oxaliplatin

60 mg/m² on Day 1 of a 14 day cycle

DRUG

5-FU

2400 mg/m² continuous IV infusion in 46 h

DRUG

LV

400 mg/m² on Day 1 of a 14 day cycle

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Jin Gang, Professor · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-04-01
Completion
2027-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210360 on ClinicalTrials.gov