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Trial Title:
HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer
NCT ID:
NCT06383078
Condition:
Efficacy and Safety
Conditions: Official terms:
Leucovorin
Folic Acid
Oxaliplatin
Fluorouracil
Irinotecan
Tegafur
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HR070803
Description:
HR070803 60 mg/^2 D1 over 90 minutes.
Arm group label:
HR070803+Oxaliplatin+5-FU/LV
Arm group label:
HR070803+Oxaliplatin+S-1
Other name:
Irinotecan Liposome
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin 85 mg/^2 D1 over 2 hours.
Arm group label:
HR070803+Oxaliplatin+5-FU/LV
Arm group label:
HR070803+Oxaliplatin+S-1
Other name:
L-OHP
Intervention type:
Drug
Intervention name:
Tegafur
Description:
initial dose of S-1 is determined according to the body surface area，orally, D1-7.
Arm group label:
HR070803+Oxaliplatin+S-1
Other name:
S-1
Intervention type:
Drug
Intervention name:
Folinic acid
Description:
Folinic acid 400 mg/^2 D1
Arm group label:
HR070803+Oxaliplatin+5-FU/LV
Other name:
LV
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours
Arm group label:
HR070803+Oxaliplatin+5-FU/LV
Other name:
5-FU
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 20, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383078
