RecruitingPhase 2NCT06445881

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

60 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Perioperative Complication

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a traditional Chinese herbal medicine called Modified Si Jun Zi Tang — a formula traditionally used to support digestion and energy — to standard treatment (immunotherapy plus chemotherapy before and after surgery) improves outcomes in patients with non-small cell lung cancer being treated with the intent to cure. **You may be eligible if...** - You are between 18 and 75 years old with confirmed, untreated non-small cell lung cancer (stage II–IIIB) - Your tumor is considered potentially removable by surgery after a multidisciplinary review - You are in good health (ECOG 0–1) with adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have a history of autoimmune disease, active tuberculosis, HIV, or active hepatitis - You have a heart or lung condition that makes surgery too risky - You have had another cancer in the past 2 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGModified 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.

Locations(1)

the First Affilated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06445881

Related Trials

Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)

NCT066944541 location

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

NCT0500540346 locations