Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445881
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-06-02
Brief Title:
Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
A Multi-center Prospective Exploratory Study Evaluating the Efficacy and Safety of a Modified Si Jun Zi Tang Formula in the Perioperative Treatment of Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
MSJZT-NSCLC
Brief Summary:
Chemotherapy combined with immunotherapy is the current standard perioperative treatment for non-small cell lung cancer NSCLC However this regimen has multiple side effects and shows variable efficacy among individuals In China adjunctive traditional Chinese medicine is widely accepted by lung cancer patients Modified Si Jun Zi Tang a classic formula in traditional Chinese medicine is known for its benefits in unifying and strengthening the spleen This study aims to evaluate whether the addition of Modified Si Jun Zi Tang to chemotherapy and immunotherapy during the neoadjuvant phase can improve the R0 resection rate objective response rate ORR and safety in patients with resectable and potentially resectable NSCLC Secondary objectives include assessing whether this combination can improve 1-year and 2-year disease-free survival DFS post-surgery Additionally we will collect relevant biological samples to identify tumor markers associated with efficacy prognosis and side effects providing a theoretical basis for modernizing and standardizing traditional Chinese medicine
Detailed Description:
None
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