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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Modified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.
the First Affilated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGR0 Resection Rate
The proportion of patients achieving complete surgical resection with negative margins (R0 resection) after neoadjuvant therapy.
Time frame: Assessed at the time of surgery, approximately 2-4 months after starting treatment.
Objective Response Rate (ORR)
The proportion of patients achieving partial or complete response as defined by RECIST v1.1 criteria.
Time frame: Assessed after 2 cycles of treatment (approximately 6 weeks) and before surgery, if applicable.
Incidence of Adverse Reactions
The proportion of patients experiencing treatment-related adverse reactions, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Assessed throughout the treatment period, from the start of treatment up to one year post-surgery.
1-Year Disease-Free Survival (DFS)
The proportion of patients who remain free of disease recurrence or progression one year after surgery.
Time frame: Assessed one year post-surgery.
2-Year Disease-Free Survival (DFS)
The proportion of patients who remain free of disease recurrence or progression two years after surgery.
Time frame: Assessed two years post-surgery.
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