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HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer

NCT06383078 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.

Conditions

  • Efficacy and Safety

Interventions

DRUG

HR070803

HR070803 60 mg/\^2 D1 over 90 minutes.

DRUG

Oxaliplatin

Oxaliplatin 85 mg/\^2 D1 over 2 hours.

DRUG

Tegafur

initial dose of S-1 is determined according to the body surface area，orally, D1-7.

DRUG

Folinic acid

Folinic acid 400 mg/\^2 D1

DRUG

5-Fluorouracil

5-FU 2400 mg/\^2 D1 IV continuous infusion over 46 hours

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2027-03-01
Completion
2027-12-30

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Drugs

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 NCT06383078 on ClinicalTrials.gov