Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07586891

Randomized, Double-Blind Study of Low Branched-Chain Amino Acid Diet with Anti-PD-1 Antibody for Stage III Melanoma

Led by Xijing Hospital · Updated on 2026-05-14

80

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effects of a low branched-chain amino acid (BCAA) diet combined with an anti-PD-1 monoclonal antibody as neoadjuvant therapy in patients with stage III melanoma. The study aims to document adverse events, assess tumor response rates, and analyze long-term survival. It also explores quality of life and potential biomarkers linked to treatment outcomes. Participants are randomly assigned to either a standard diet with anti-PD-1 therapy or a low BCAA diet combined with anti-PD-1 therapy. The treatments occur before surgery, and the study is double-blind and controlled. The intervention period lasts up to three months, during which participants receive dietary guidance and the antibody treatment. Throughout the study, participants undergo regular physical exams, vital sign monitoring, laboratory tests including blood counts and liver function, and heart evaluations every few weeks. Tumor measurements and pathological assessments occur at baseline and after treatment. Researchers also evaluate quality of life and monitor participants during long-term follow-up to assess survival and treatment effects.

CONDITIONS

Brief 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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed stage III malignant melanoma with at least one accessible lymph node or in-transit metastasis
  • No prior radiotherapy or systemic chemotherapy or recent immunotherapy within the last month
  • Life expectancy of at least 6 months
  • At least one measurable tumor lesion
  • Age between 18 and 75 years
  • Eastern Cooperative Oncology Group performance status score of 0 or 1
  • Adequate organ function based on specified blood counts and liver and kidney tests
  • Negative pregnancy test for women of childbearing potential
  • Willingness to use contraception for up to 12 months after last dose for women of childbearing potential
  • Written informed consent to participate voluntarily
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial with investigational drugs or devices within 4 weeks prior to study
  • Anti-tumor therapy received within the past month
  • Recent systemic corticosteroid or immunosuppressive therapy
  • History of hematologic malignancies, brain tumors, sarcoma, or other solid tumors unless cured with no recurrence for 5 years
  • Known central nervous system metastases or carcinomatous meningitis
  • History of severe allergic reaction to monoclonal antibody therapy
  • Active autoimmune disease requiring systemic treatment within past 2 years
  • Severe uncontrolled conditions such as advanced heart failure, unstable angina, severe infections, or pulmonary disease
  • Positive tests for HIV, hepatitis B or C, or tuberculosis
  • Recent live vaccine or growth factor therapy
  • Major surgery within 2 weeks prior to treatment
  • Psychiatric or substance abuse disorders interfering with trial compliance
  • Pregnant or breastfeeding women or those planning pregnancy
  • Any other severe medical or psychiatric condition increasing risk or interfering with results

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 months

Participants receive either a low branched-chain amino acid diet combined with anti-PD-1 therapy or standard diet with anti-PD-1 therapy and other essential drugs.

Visits every 3 weeks for assessments and every 8 weeks for cardiac monitoring

Trial Site Locations

Total: 1 location

1

Xijing Hospital, Air Force Medical University

Xi'an, China

Actively Recruiting

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Research Team

W

Weinan Guo

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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Published Research Related To This Trial

Role of branched-chain amino acid-catabolizing enzymes in intertissue signaling, metabolic remodeling, and energy homeostasis.

Dipsikha Biswas, Luke Duffley, Thomas Pulinilkunnil

https://pubmed.ncbi.nlm.nih.gov/31084571

Downregulation of AMPK accompanies leucine- and glucose-induced increases in protein synthesis and insulin resistance in rat skeletal muscle.

Asish K Saha, X Julia Xu, Ebony Lawson...

https://pubmed.ncbi.nlm.nih.gov/20682696

A joint analysis of transcriptomic and metabolomic data uncovers enhanced enzyme-metabolite coupling in breast cancer.

Noam Auslander, Keren Yizhak, Adam Weinstock...

https://pubmed.ncbi.nlm.nih.gov/27406679