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

HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Efficacy and Safety
• Intervention / Treatment: Drug: HR070803; Drug: Oxaliplatin; Drug: Tegafur; Drug: Folinic acid; Drug: 5-Fluorouracil

Detailed Description

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the 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. Patients without event at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria also include the Disease-free survival.

Tolerance Patients evaluable for toxicity must have received one investigational drug.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
3. CA19-9 exceeding normal value within 14 days prior to enrollment.
4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
5. 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;
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR070803+Oxaliplatin+S-1; 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; HR070803 60 mg/^2 D1 over 90 minutes.; Other Names: Irinotecan Liposome; Drug: Oxaliplatin; Oxaliplatin 85 mg/^2 D1 over 2 hours.; Other Names: L-OHP; Drug: Tegafur; initial dose of S-1 is determined according to the body surface area，orally, D1-7.; Other Names: S-1
Active Comparator: HR070803+Oxaliplatin+5-FU/LV; 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; HR070803 60 mg/^2 D1 over 90 minutes.; Other Names: Irinotecan Liposome; Drug: Oxaliplatin; Oxaliplatin 85 mg/^2 D1 over 2 hours.; Other Names: L-OHP; Drug: Folinic acid; Folinic acid 400 mg/^2 D1; Other Names: LV; Drug: 5-Fluorouracil; 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours; Other Names: 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from date of randomization until the date of death from any cause.	Up to 2 years
Disease-free survival（DFS）	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Topoisomerase Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Hematinics; Fluorouracil; Oxaliplatin; Leucovorin; Irinotecan; Levoleucovorin; Folic Acid; Tegafur
• Other Study ID Numbers: MA-PC-II-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No