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NCT06445881: MSJZT-NSCLC

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

Recruiting now Phase 2 Last updated 6 June 2024
What this trial tests

Phase 2 trial testing Modified Si Jun Zi Tang in Non Small Cell Lung Cancer in 60 participants. Currently enrolling.

Timeline
1 June 2024
Primary endpoint
31 December 2025
31 December 2026

Quick facts

Lead sponsorFirst Affiliated Hospital of Zhejiang University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date1 June 2024
Primary completion31 December 2025
Estimated completion31 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

Adults 18 to 75, any sex, with Non Small Cell Lung Cancer or Perioperative Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Traditional Chinese medicine in lung cancer treatment.
    Xi Z, Dai R, Ze Y, Jiang X, et al · · 2025 · cited 61× · PMID 40001110 · DOI 10.1186/s12943-025-02245-6

Verify or expand the search:

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

Other First Affiliated Hospital of Zhejiang University trials

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