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Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer

NCT06259058 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-03-15

No results posted yet for this study

Summary

This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).

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-Fluorouracil

2400 mg/m² continuous IV infusion in 46 h

DRUG

Leucovorin

400 mg/m² on Day 1 of a 14-day cycle

RADIATION

SBRT

30Gy/5Fx

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Jihui Hao, Professor · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-04-01
Completion
2027-12-01

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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 NCT06259058 on ClinicalTrials.gov