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

NCT ID: NCT06383078

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2027-12-30

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.

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.

Conditions

Efficacy and Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HR070803

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Tegafur

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

HR070803

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Folinic acid

Intervention Type: DRUG

Folinic acid 400 mg/\^2 D1

5-Fluorouracil

Intervention Type: DRUG

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

Interventions

HR070803

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Tegafur

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

Intervention Type: DRUG

Folinic acid

Folinic acid 400 mg/\^2 D1

Intervention Type: DRUG

5-Fluorouracil

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

Intervention Type: DRUG

Other Intervention Names

Irinotecan Liposome; L-OHP; S-1; LV; 5-FU

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MA-PC-II-012

Identifier Type: -

Identifier Source: org_study_id