1. Primary Objective: To evaluate the safety of a low branched-chain amino acid diet (60% of the normal dietary BCAA content) combined with anti-PD-1 monoclonal antibody as neoadjuvant therapy in patients with stage III melanoma, by documenting the incidence of all adverse events (AEs) and serious adverse events (SAEs), and analyzing changes from baseline in physical examinations, vital signs, and laboratory test results. 2. Secondary Objectives: To assess the pathological response rates (including pCR, near-pCR, pPR, and pNR) of the combination therapy in stage III melanoma; to evaluate the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the immune-related RECIST (irRECIST) criteria; and to estimate event-free survival (EFS) and overall survival (OS) through long-term follow-up. 3. Exploratory Objectives: To investigate the quality of life (QoL) in patients receiving the low BCAA diet combined with anti-PD-1 therapy; and to identify predictive biomarkers for treatment outcome differences, such as immune-related gene signatures (e.g., PD-L1 expression) and driver gene mutations in somatic variants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
The experimental group receives a low branched-chain amino acid diet
Xijing Hospital, Air Force Medical University
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
Left ventricular ejection fraction (LVEF)
LVEF assessed by echocardiography.
Time frame: Baseline and every 8 weeks through study completion (up to 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)
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 level 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 level 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., ultrasonography, 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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