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

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 evalua

Trial Details

NCT ID
NCT07586891
Phase
NA
Sponsor
Xijing Hospital
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Low Branched-Chain Amino Acid Diet
Locations (sample)
  • Xi'an, China|34.25833,108.92861

Key Eligibility Criteria

  • Patients with histopathologically or cytologically confirmed Stage III malignant melanoma. Stage III is defined as the presence of at least one cli…
  • No prior radiotherapy or systemic chemotherapy. No treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibodies, anti-CTLA-4 monoclonal a…
  • Life expectancy ≥ 6 months.
  • At least one measurable lesion as defined by RECIST version 1.1.

For full eligibility, visit ClinicalTrials.gov.

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