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

NCT06445881 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jianzhen Shan, MD · the First Affiliated Hospital of Zhejiang Universtiy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445881 on ClinicalTrials.gov