NCT06445881

Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer
• Perioperative Complication

Interventions

Type	Name	Description
DRUG	Modified Si Jun Zi Tang	Modified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-06-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: China