1. Primary Objective To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III/IV melanoma. Assessments include: Target lesion response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) Objective response rate (ORR) Pathological response rate (pathological complete response \[pCR\], near pCR, pathological partial response \[pPR\], pathological non-response \[pNR\]) Incidence of all adverse events (AEs) and serious adverse events (SAEs) Changes from baseline in physical examinations, vital signs, and laboratory test results. 2. Exploratory Objectives To investigate the correlation between treatment efficacy/patient outcomes and:PD-L1 expression in tumor tissue CD8+ T-cell infiltration Tumor mutational burden (TMB). 3. Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Cadonilimab: 10 mg/kg administered via intravenous infusion every 3 weeks. The neoadjuvant treatment course consists of 4 cycles, totaling 3 months. Recombinant Human Interferon α1b Injection: 600 μg administered subcutaneously every other day. The neoadjuvant treatment course is 3 months. If intolerable (e.g., occurrence of Grade 3 or 4 adverse reactions or other qualifying events), the dose should be reduced to 300 μg subcutaneously every other day.
Xijing Hospital, Air Force Medical University Xi'an, Shaanxi, China
Xi'an, China
RECRUITINGSystolic blood pressure
Systolic blood pressure
Time frame: through study completion, an average of 3 months
respiratory rate
respiratory rate
Time frame: through study completion, an average of 3 months
body temperature
body temperature
Time frame: through study completion, an average of 3 months
heart rate
heart rate
Time frame: through study completion, an average of 3 months
Hemoglobin concentration
Hemoglobin concentration assessed by complete blood count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Left ventricular ejection fraction (LVEF)
LVEF assessed by echocardiography
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
White blood cell count
White blood cell count assessed by complete blood count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Platelet count
Platelet count assessed by complete blood count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Alanine aminotransferase (ALT) level
ALT level measured from clinical biochemistry panel
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Aspartate aminotransferase (AST) level
AST level measured from clinical biochemistry panel
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Creatinine level
Creatinine level measured from clinical biochemistry panel
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Blood glucose level
Blood glucose level measured from clinical biochemistry panel (fasting or as specified in protocol)
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Lactate dehydrogenase (LDH) level
LDH measured from clinical biochemistry panel
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Triiodothyronine (T3) level
T3 level measured from blood sample.
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Thyroid-stimulating hormone (TSH) level
TSH levell measured from blood sample.
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Left ventricular end-diastolic diameter (LVEDD)
LVEDD assessed by echocardiography
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
Cardiac output
Cardiac output estimated by echocardiography
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
PR interval
PR interval assessed by 12-lead electrocardiography
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
QRS duration
QRS duration assessed by 12-lead electrocardiography
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
Lymph node target lesion short-axis diameter
Short axis diameter of target lesions in lymph nodes, assessed by imaging (e. g., utrasonography, CT,or MRI per schedule of assessments
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Percentage of residual viable tumor cells in lymph nodes
Proportion of viable tumor cells in lymph node tissue assessed by histopathological analysis.
Time frame: Perioperative (after 3 months of treatment)
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