Actively Recruiting
Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma
Led by Xijing Hospital · Updated on 2026-05-14
80
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histopathologically or cytologically confirmed Stage III malignant melanoma with at least one clinically accessible lymph node or in-transit metastasis
- No prior radiotherapy or systemic chemotherapy and no treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, interferon, or targeted agents within the last month
- Life expectancy of at least 6 months
- At least one measurable lesion defined by RECIST version 1.1
- Between 18 and 75 years of age at consent
- ECOG performance status of 0 or 1
- Adequate organ function within 4 weeks prior to treatment based on blood counts, liver and kidney function, and coagulation tests
- Negative pregnancy test within 7 days prior to first dose for women of childbearing potential
- Willingness to use adequate contraception for up to 12 months after last dose for women of childbearing potential
You will not qualify if you...
- Participation in another investigational drug or device trial within 4 weeks prior to first dose
- Receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy, within the past month
- Systemic corticosteroid therapy (>10 mg/kg prednisone or equivalent) within 2 weeks prior to first dose or other immunosuppressive therapy
- History of hematologic malignancies, primary brain tumors, sarcoma, or other primary solid tumors unless cured and no recurrence for 5 years (exceptions for basal cell carcinoma and carcinoma in situ of the cervix)
- Known central nervous system metastases or carcinomatous meningitis
- History of severe hypersensitivity reaction to monoclonal antibody therapy
- Active autoimmune disease requiring systemic treatment in past 2 years (except certain conditions)
- Severe uncontrolled co-morbid conditions including advanced infections, significant cardiovascular or pulmonary disease, HIV, hepatitis B or C, or tuberculosis
- Receipt of live vaccine within 4 weeks prior to first dose
- Receipt of hematopoietic growth factors within 2 weeks prior to treatment
- Major surgery within 2 weeks prior to treatment (excluding diagnostic surgery)
- Known psychiatric or substance abuse disorder interfering with trial participation
- Pregnancy, breastfeeding, or plans to conceive/father during study
- Any other severe or uncontrolled medical or psychiatric condition or laboratory abnormality that may increase risk or interfere with study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hospital, Air Force Medical University
Xi'an, China
Actively Recruiting
Research Team
W
Weinan Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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