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

Efficacy and Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383078
• Other study ID #: MA-PC-II-012
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 20, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy and Safety

Intervention

Drug:
• HR070803
HR070803 60 mg/^2 D1 over 90 minutes.
• Oxaliplatin
Oxaliplatin 85 mg/^2 D1 over 2 hours.
• Tegafur
initial dose of S-1 is determined according to the body surface area,orally, D1-7.
• Folinic acid
Folinic acid 400 mg/^2 D1
• 5-Fluorouracil
5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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