Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383078
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-03
Brief Title:
HR070803 in Combination With Oxaliplatin S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-fluorouracilleucovorin 5FULV 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None