Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
NCT ID: NCT06445881
Last Updated: 2024-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-06-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified Si Jun Zi Tang Combined with Chemotherapy and Immunotherapy
Participants will receive Modified Si Jun Zi Tang combined with chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with Modified Si Jun Zi Tang and PD1 monoclonal antibody for up to one year.
Modified Si Jun Zi Tang
Modified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.
Standard Chemotherapy and Immunotherapy
Participants will receive standard chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with PD1 monoclonal antibody for up to one year.
No interventions assigned to this group
Interventions
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Modified Si Jun Zi Tang
Modified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed non-small cell lung cancer (NSCLC) with no prior treatment for this tumor.
3. Clinical stage II-IIIB (N2) tumors assessed as resectable or potentially resectable by a multidisciplinary team (MDT).
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
5. Adequate organ function, including:
Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 80 x 10\^9/L, hemoglobin ≥ 90 g/L.
Liver: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 times ULN.
Kidneys: Creatinine clearance rate ≥ 45 mL/min (using the standard Cockcroft-Gault formula) or ≤ 1.5 times ULN.
6. At least one measurable lesion according to RECIST v1.1 criteria.
7. For women: Must be surgically sterilized, postmenopausal, or use highly effective contraception during and for 3 months after treatment; must not be pregnant or breastfeeding during the treatment period.
8. Patients must have compliance and geographic proximity to ensure adequate follow-up.
Exclusion Criteria
2. 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).
3. 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.
4. 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.).
5. Significant cardiovascular events: congestive heart failure \> NYHA Class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction over 1 year before study entry is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension.
6. Significant neurological or psychiatric disorders, including epilepsy, dementia, etc.
7. Patients with interstitial lung disease or a history of interstitial pneumonia.
8. Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment.
9. Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs.
10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation.
11. Known allergy to the drugs or drug excipients used in the study or severe allergic reactions to other monoclonal antibodies.
12. Presence of other severe physical or laboratory abnormalities that may increase the risk of participating in the study, interfere with study results, or any other condition that, in the investigator's judgment, may affect the conduct or results of the clinical study.
18 Years
75 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jianzhen Shan, MD
Role: PRINCIPAL_INVESTIGATOR
the First Affiliated Hospital of Zhejiang Universtiy
Locations
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the First Affilated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT20240018C-R1
Identifier Type: -
Identifier Source: org_study_id
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