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

NCT06383078 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-PC-II-012
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 1-year Disease-free survival rate

  Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.

  Up to 2 years

Secondary Outcomes (2)

• Overall survival (OS)

  Up to 2 years

• Disease-free survival（DFS）

  Up to 2 years

Study Arms (2)

HR070803+Oxaliplatin+S-1

EXPERIMENTAL

Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/\^2 D1 over 90 minutes. Oxaliplatin 85 mg/\^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7. These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.

Drug: HR070803; Drug: Oxaliplatin; Drug: Tegafur

HR070803+Oxaliplatin+5-FU/LV

ACTIVE COMPARATOR

Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/\^2 D1 over 90 minutes. Oxaliplatin 85 mg/\^2 D1 over 2 hours. Folinic acid 400 mg/\^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/\^2 D1 IV continuous infusion over 46 hours. These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.

Drug: HR070803; Drug: Oxaliplatin; Drug: Folinic acid; Drug: 5-Fluorouracil

Interventions

HR070803 DRUG

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

Also known as: Irinotecan Liposome

HR070803+Oxaliplatin+5-FU/LV; HR070803+Oxaliplatin+S-1

Oxaliplatin DRUG

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

Also known as: L-OHP

HR070803+Oxaliplatin+5-FU/LV; HR070803+Oxaliplatin+S-1

Tegafur DRUG

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

Also known as: S-1

HR070803+Oxaliplatin+S-1

Folinic acid DRUG

Folinic acid 400 mg/\^2 D1

Also known as: LV

HR070803+Oxaliplatin+5-FU/LV

5-Fluorouracil DRUG

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

Also known as: 5-FU

HR070803+Oxaliplatin+5-FU/LV

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
• ECOG performance status 0 or 1.
• Life expectancy of greater than or equal to 6 months.
• Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
• The number of lymph nodes dissected during resection ≥ 15.
• Able and willing to provide a written informed consent.

You may not qualify if:

• Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
• Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
• CA19-9 exceeding normal value within 14 days prior to enrollment.
• Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
• Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
• Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Interventions

irinotecan sucrosofate; Oxaliplatin; Tegafur; S 1 (combination); Leucovorin; Fluorouracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 25, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share