Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and ≤ 75 years.
Pathologically confirmed non-small cell lung cancer (NSCLC) with no prior treatment for this tumor.
Clinical stage II-IIIB (N2) tumors assessed as resectable or potentially resectable by a multidisciplinary team (MDT).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
Disqualifiers
Patients with a history of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA <2000 IU), or HIV infection.
Patients expected to be unable to tolerate surgery, such as those with severe cardiopulmonary insufficiency or coagulation disorders (APTT <1.5 times ULN, INR >2.0, PT >16 seconds).
History of other malignancies within the past 2 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, superficial bladder cancer [Ta, Tis & T1], or papillary thyroid carcinoma.
Any unstable systemic disease (including active systemic infections requiring systemic treatment, liver disease, kidney disease, or metabolic disorders, acute cerebral infarction or cerebral hemorrhage, etc.).
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Si Jun Zi Tang
DrugModified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Modified Si Jun Zi Tang Combined with Chemotherapy and ImmunotherapyExperimental treatment 1 intervention
Group B: Standard Chemotherapy and ImmunotherapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
R0 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.2
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.3
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.Secondary outcomes
1
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
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.Sponsors and contacts
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Source ClinicalTrials.gov