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NCT06445881: MSJZT-NSCLC
Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
Phase 2 trial testing Modified Si Jun Zi Tang in Non Small Cell Lung Cancer in 60 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 June 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Modified Si Jun Zi Tang — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
- Perioperative Complication — all drugs for Perioperative Complication →
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):
-
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:
- PubMed search for NCT06445881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06445881 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Zhejiang University
- Last refreshed: 6 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06445881.
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