Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Bra
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)
| Condition(s) | Melanoma (Skin Cancer) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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) an |
| Who can participate | Inclusion Criteria: * Patients with histopathologically or cytologically confirmed Stage III malignant melanoma. Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis. Patients with mucosal or ocular melanoma are excluded; those with melanoma of unknown primary are also excluded. * No prior radiotherapy or systemic chemotherapy. No treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibodies, anti-CTLA-4 monoclonal antibody, interferon (IFN), or targeted agents within the last month. * Life expectancy ≥ 6 months. * At least one measurable lesion as defined by RECIST version 1.1. * Patients must have provided written informed consent to participate voluntarily in this trial and must be between 18 and 75 years of a |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Xijing Hospital |
| Locations | Xi'an, China |
| Start date | 2024-07-01 |
| NCT ID | NCT07586891 |
| Official listing | https://clinicaltrials.gov/study/NCT07586891 |