Last updated: August 22, 2023
Sponsor: Dong Wang
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Chemotherapy drug
bronchial artery interventional therapy
Immunotherapy
Clinical Study ID
NCT05892237
2023108
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients volunteered to participate in the study and signed the informed consent.
- Age 18-80, both male and female.
- Histologically or cytologically confirmed squamous lung cancer staging T3-4, Nany, andM0 (according to the American Joint Committee on Cancer Staging (AJCC) 2017 Edition 8TNM Staging System). Central-type classified according to chest imaging orbronchoscopy.
- At least one measurable lesion according to RECIST 1.1.
- ECOG PS 0-1.
- Expected survival ≥ 6 months.
- Patients who never received systemic therapy in the past, including radiotherapy,chemotherapy, targeted therapy and immunotherapy, or patients who relapsed more than 6months after adjuvant chemotherapy.
- The main organ functions accorded with the following criteria within 7 days beforetreatment:
- Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 *109/L; platelet (PLT) ≥80 *109/L.
- Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) andaspartate aminotransferase (AST) ≤2.5 ULN, if accompanied by liver metastasis,ALT and AST ≤ 5 ULN; 3) serum creatinine (Cr) ≤ 1.5* ULN or creatinine clearancerate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L). (3) Doppler echocardiography:left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
- Tissue samples should be provided for biomarker analysis (such as PD-L1) Patients whocould not provide new tissues could provide 5-8 paraffin sections of 3-5 μm byarchival preservation. Blood sample should be collected at a pre-specified time pointto complete the continuous dynamic MRD analysis. (non-mandatory).
Exclusion
Exclusion Criteria:
- Severe allergic reactions to humanized antibodies or fusion proteins in the past.
- Severe allergic reactions to component contained in contrast agent or granule embolismagent in the past.
- Metastasis to bone, brain, liver, pleural cavity, or any other distant organs.
- Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any otherform of immunosuppressive therapy within 14 days before the study, allowingphysiological doses of glucocorticoids (≤10mg/day prednisone or equivalent).
- Patients with active, known or suspected autoimmune diseases. Patients with type Idiabetes, hypothyroidism requiring hormone replacement therapy, skin disordersrequiring no systemic treatment (such as vitiligo, psoriasis or alopecia). Patientswho would not triggers can be included.
- Serious heart disease, include congestive heart failure, uncontrollable high-riskarrhythmia, unstable angina pectoris, myocardial infarction, and severe valvulardisease.
- Patients received systemic antineoplastic therapy, including cytotoxic therapy, signaltransduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before thegrouping),recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before thegrouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeksbefore the grouping.
- Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
- Patients with active pulmonary tuberculosis (TB) infection judged by chest X-rayexamination, sputum examination and clinical physical examination. Patients withactive pulmonary tuberculosis infection in the previous year should be excluded evenif they have been treated; Patients with active pulmonary tuberculosis infection morethan a year ago should also be excluded unless the course and type of antituberculosistreatment previously were appropriate.
- Patients with brain metastases with symptoms or symptoms controlling less than 2months.
Study Design
Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Chemotherapy drug
Phase: 2
Study Start date:
July 01, 2023
Estimated Completion Date:
June 01, 2026
Study Description
Connect with a study center
Daping Hospital, Third Military Medical University
Chongqing, Chongqing 400042
ChinaActive - Recruiting
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