Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 10:15 PM
Study NCT ID:
NCT06387368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer
Sponsor:
Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer
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:
This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.
Detailed Description:
This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.
Study Oversight
Has Oversight DMC:
True
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?: