Tests D-BACE with chemotherapy and camrelizumab before surgery for lung cancer

Trial details

Who runs it

Guangdong Provincial People's Hospital

Trial code

NCT07016126

Record updated

26 October 2026

Original description

This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable stage II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC. Forty-six subjects will be enrolled in this prospective observation, using a Simon two-stage optimal design, aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and camrelizumab in patients with resectable stage II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The primary endpoint is the major pathological response (MPR) rate, defined as no more than 10% residual viable tumor cells in the primary tumor bed upon comprehensive pathological assessment. The treatment group regimen will be 3 cycles of D-BACE (DCB drug-eluting microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and camrelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-based doublet chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.Read full original descriptionShow less

A Phase II, Single-Arm, Single-Center Study of D-BACE in Combination With Chemotherapy and Camrelizumab for Resectable or Potentially Resectable II-IIIA or T3-4N2 Stage IIIB NSCLC

This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable stage II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC. Forty-six subjects will be enrolled in this prospective observation, using a Simon two-stage optimal design, aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and camrelizumab in patients with resectable stage II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The primary endpoint is the major pathological response (MPR) rate, defined as no more than 10% residual viable tumor cells in the primary tumor bed upon comprehensive pathological assessment. The treatment group regimen will be 3 cycles of D-BACE (DCB drug-eluting microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and camrelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-based doublet chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.

Inclusion: Only patients who meet all of the following criteria are eligible for inclusion in this study:; Provide written informed consent Male or female, aged 18 to 75 years Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Measurable disease in accordance with RECIST version 1.1; Subjects must be able to provide a specimen containing tumor tissue or have a newly resected tumor biopsy sample available for PD-L1 immunohistochemistry (IHC) testing at a central laboratory during the screening phase:; Before treatment, formalin-fixed, paraffin-embedded (FFPE) tissue blocks or unstained tumor tissue sections and relevant pathology reports must be submitted for biomarker assessment. Tumor tissue specimens may be fresh or archived within 6 months before enrollment; The tissue must be a core needle biopsy section, excisional biopsy section, or incisional biopsy section; It is recommended that fresh paraffin sections (PD-L1 assay to be performed within 7 days of sectioning) be stored and transported in the dark; It is recommended that fresh tissue be fixed in 10% neutral buffered formalin for 24 to 48 hours; The patient's lung function or other organ function must be evaluated by a surgeon as adequate to tolerate local surgical treatment; Adequate organ function assessment and laboratory screening must be performed within 7 days prior to initiation of therapy; Reproductive status:; Women of childbearing potential must have a negative pregnancy test (serum or urine) within 72 hours before the start of treatment; Women must be non-lactating. Female patients must use appropriate contraception during treatment and for 6 months after the last dose of treatment; Male subjects must agree to use appropriate contraception during treatment and for 7 months after the last dose of treatment, and must be willing to avoid donating sperm during this period.

Exclusion: Medical conditions Stage I, IIIB/IIIC (N3), and stage IV NSCLC. Patients with previous immune checkpoint inhibitor (ICI) immunotherapy, targeted therapy, chemotherapy, or other systemic antitumor therapies; Patients with active hepatitis B (positive hepatitis B surface antigen [HBsAg] test) or hepatitis C (positive HCV RNA test). Patients with previous HBV infection or resolved HBV infection (defined as positive hepatitis B core antibody [HBcAb] and negative HBsAg) are eligible to participate; these patients must provide HBV DNA test results before enrollment. Patients who are HBV carriers or require antiviral therapy are not eligible. Patients who test positive for HCV antibodies are eligible only if they have negative HCV RNA by PCR; Patients with contraindications to local treatment (including surgery or intervention) as judged by the investigator; Active known or suspected autoimmune disease. Subjects are eligible if they have type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin conditions (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or other conditions not expected to recur in the absence of an external trigger; Patients with a history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS); Any history of arterial thrombosis within 6 months. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months; Uncontrolled angina, arrhythmia, or congestive heart failure. Other active malignancy within 5 years (except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, superficial bladder cancer, prostate cancer, or breast carcinoma in situ); Serious or uncontrolled medical illness. Patients with psychosis or other conditions resulting in treatment nonadherence; Other exclusion criteria Prisoners or subjects under compulsory confinement. Subjects involuntarily detained for treatment of mental or physical illness (e.g., infectious disease); Patients with brain metastases. Patients with allergy to contrast media. Patients whose tumors have targeted alterations in EGFR and/or ALK, or known targeted alterations in ROS1, BRAF, HER-2, NTRK, MET, or RET. Patients with K-RAS mutations are eligible; History of severe hypersensitivity reactions to other monoclonal antibodies. Patients who are unwilling to sign the informed consent form. Patients who are unwilling to undergo follow-up. Physical and laboratory examinations; Laboratory screening values must not meet any of the following criteria (CTCAE version 5.0 applies):; White blood cell count < 2,000/μL Neutrophil count < 1,500/μL Platelet count < 100 × 10³/μL Hemoglobin < 9.0 g/dL; Serum total bilirubin > 1.5 times the upper limit of normal (ULN) In the presence of liver metastases, AST and ALT > 5 × ULN, and total bilirubin > 1.5 × ULN; Abnormal coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN; if the subject is receiving anticoagulant therapy, PT must be outside the intended therapeutic range of the anticoagulant drug; Urine protein > 2+, or 24-hour urinary protein ≥ 1 g Serum creatinine > 1.5 × ULN, or calculated creatinine clearance (CrCl) < 50 mL/min (using the Cockcroft-Gault formula) Female CrCl = ([140 - age] × weight [kg] × 0.85) / (72 × serum creatinine [mg/dL]) Male CrCl = ([140 - age] × weight [kg] × 1.00) / (72 × serum creatinine [mg/dL]) Allergy and drug hypersensitivity History of hypersensitivity to other monoclonal antibodies. History of allergic or hypersensitivity reactions to components of the study drugs; Bone marrow function:; Liver function:; Coagulation function:; Renal function:.

ClinicalTrials.gov NCT07016126