Efficacy and Safety
Conditions
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.
Interventions
DRUGHR070803
HR070803 60 mg/\^2 D1 over 90 minutes.
DRUGOxaliplatin
Oxaliplatin 85 mg/\^2 D1 over 2 hours.
DRUGTegafur
initial dose of S-1 is determined according to the body surface area，orally, D1-7.
DRUGFolinic acid
Folinic acid 400 mg/\^2 D1
DRUG5-Fluorouracil
5-FU 2400 mg/\^2 D1 IV continuous infusion over 46 hours
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Disease-free survival rate | Up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 2 years | OS is defined as the time from date of randomization until the date of death from any cause. |
| Disease-free survival（DFS） | Up to 2 years | 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. |
Outcome results
None listed