Actively Recruiting
Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-06-06
60
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years.
- Pathologically confirmed non-small cell lung cancer (NSCLC) with no previous treatment.
- Clinical stage II to IIIB (N2) tumors considered resectable or potentially resectable by a multidisciplinary team.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate bone marrow function: absolute neutrophil count 21.5 x 10^9/L, platelets 20 x 10^9/L, hemoglobin 18 g/L.
- Adequate liver function: total bilirubin 1.5 times upper limit of normal, AST and ALT 3 times upper limit of normal.
- Adequate kidney function: creatinine clearance rate 245 mL/min or 1.5 times upper limit of normal.
- At least one measurable tumor lesion according to RECIST v1.1 criteria.
- For women, surgically sterilized, postmenopausal, or using highly effective contraception during treatment and for 3 months after; not pregnant or breastfeeding.
- Ability to comply with study requirements and located within geographic proximity for follow-up.
You will not qualify if you...
- History of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA <2000 IU), or HIV infection.
- Unable to tolerate surgery due to severe cardiopulmonary insufficiency or coagulation disorders.
- History of other cancers within the past 2 years, except certain cured or low-risk cancers.
- Unstable systemic diseases including active infections requiring treatment, liver or kidney diseases, metabolic disorders, or recent stroke.
- Significant cardiovascular problems such as severe heart failure, unstable angina, active coronary artery disease, serious arrhythmias, or uncontrolled hypertension.
- Significant neurological or psychiatric disorders including epilepsy or dementia.
- Presence or history of interstitial lung disease or interstitial pneumonia.
- Participation in other anti-tumor drug trials within 4 weeks before enrollment.
- Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapies.
- History or planned allogeneic organ or hematopoietic stem cell transplantation.
- Known allergy to study drugs or severe reactions to other monoclonal antibodies.
- Other severe physical or laboratory abnormalities that increase risk or interfere with study conduct or results.
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Trial Site Locations
Total: 1 location
1
the First Affilated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jianzhen Shan, MD
CONTACT
Z
Zhen Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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