Melanoma (Skin Cancer)NCT07586891
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
A study testing Low Branched-Chain Amino Acid Diet in people with Melanoma (Skin Cancer), run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Low Branched-Chain Amino Acid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 age on the day of signing the consent form.
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
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- Adequate organ function as assessed by the following laboratory values (within 4 weeks prior to the start of study drug treatment):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelets ≥ 100 × 10⁹/L
- Hemoglobin ≥ 90 g/L (no transfusion within 14 days prior to enrollment)
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 × ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)
- Prothrombin time (PT)/International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is on anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant).
- For women of childbearing potential, a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.
- Female patients of childbearing potential who enroll in the study must be willing to use adequate contraception for up to 12 months after the last dose of the study drug.
Who cannot join
- The patient is currently participating, or has participated in a clinical trial of an investigational drug or medical device within 4 weeks prior to the first dose of the study drug.
- The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.
- The patient has received systemic corticosteroid therapy (>10 mg/kg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive therapy.
- The patient has a known history of hematologic malignancies, primary brain tumors, sarcoma, or other primary solid tumors, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- The patient has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- The patient has a history of severe hypersensitivity reaction to another monoclonal antibody (mAb) therapy.
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- The patient has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with corticosteroids or immunosuppressive drugs). Replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments and are allowed. Exceptions include patients with vitiligo, type I diabetes mellitus, or childhood asthma/atopy.
- Any other severe, uncontrolled co-morbid condition that may compromise protocol compliance or interfere with the interpretation of results, including metabolic diseases, active opportunistic or advanced (severe) infections, cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months), or pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm). Also included are HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitation limit: 500 IU/mL); or a known history of tuberculosis.
- The patient has received a live vaccine within 4 weeks prior to the first dose. The patient has received hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation. The patient has undergone major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.
- The patient has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- The patient is pregnant or breastfeeding, or plans to conceive or father children during the study period.
- Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, Air Force Medical University
Xi'an
Li Chunying, + 86-29-84775406, + 86-29-84775406, lichying@fmmu.edu.cn
About this study
Official title: A Randomized, Double-Blind, Single-Center, 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
- 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.
- 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.
- 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
- Melanoma (Skin Cancer)
- Being tested
- Low Branched-Chain Amino Acid Diet
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Branched-Chain Amino Acid DietDietary supplement
The experimental group receives a low branched-chain amino acid diet
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard diet，anti-PD-1 and other essential drugs |
| Experimental Group | Experimental | Low BCAA diet, anti-PD-1 and other essential drugs Receives: Dietary Supplement: Low Branched-Chain Amino Acid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure
Measured: through study completion, an average of 3 months
respiratory rate
respiratory rate
Measured: through study completion, an average of 3 months
body temperature
body temperature
Measured: through study completion, an average of 3 months
heart rate
heart rate
Measured: through study completion, an average of 3 months
Left ventricular ejection fraction (LVEF)
LVEF assessed by echocardiography.
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
Hemoglobin concentration
Hemoglobin concentration assessed by complete blood count
Measured: 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
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Platelet count
Platelet count assessed by complete blood count
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Alanine aminotransferase (ALT) level
ALT level measured from clinical biochemistry panel
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Aspartate aminotransferase (AST) level
AST level measured from clinical biochemistry panel
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Creatinine level
Creatinine level measured from clinical biochemistry panel
Measured: 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)
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Lactate dehydrogenase (LDH) level
LDH level measured from clinical biochemistry panel
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Triiodothyronine (T3) level
T3 level measured from blood sample.
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Thyroid-stimulating hormone (TSH) level
TSH level measured from blood sample.
Measured: Baseline and every 3 weeks through study completion (up to 3 months)
Left ventricular end-diastolic diameter (LVEDD)
LVEDD assessed by echocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
Cardiac output
Cardiac output estimated by echocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
PR interval
PR interval assessed by 12-lead electrocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
QRS duration
QRS duration assessed by 12-lead electrocardiography
Measured: Baseline and every 8 weeks through study completion (up to 3 months)
Secondary outcomes (2)
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)
Measured: 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.
Measured: Perioperative (after 3 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586891
- Sponsor's protocol ID
- XJPF-LCY-V202511
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.
PubMed 21639810Biswas D, Duffley L, Pulinilkunnil T. Role of branched-chain amino acid-catabolizing enzymes in intertissue signaling, metabolic remodeling, and energy homeostasis. FASEB J. 2019 Aug;33(8):8711-8731. doi: 10.1096/fj.201802842RR. Epub 2019 May 14.
PubMed 31084571Tedesco L, Corsetti G, Ruocco C, Ragni M, Rossi F, Carruba MO, Valerio A, Nisoli E. A specific amino acid formula prevents alcoholic liver disease in rodents. Am J Physiol Gastrointest Liver Physiol. 2018 May 1;314(5):G566-G582. doi: 10.1152/ajpgi.00231.2017. Epub 2018 Jan 25.
PubMed 29368944Saha AK, Xu XJ, Lawson E, Deoliveira R, Brandon AE, Kraegen EW, Ruderman NB. Downregulation of AMPK accompanies leucine- and glucose-induced increases in protein synthesis and insulin resistance in rat skeletal muscle. Diabetes. 2010 Oct;59(10):2426-34. doi: 10.2337/db09-1870. Epub 2010 Aug 3.
PubMed 20682696Saxton RA, Knockenhauer KE, Wolfson RL, Chantranupong L, Pacold ME, Wang T, Schwartz TU, Sabatini DM. Structural basis for leucine sensing by the Sestrin2-mTORC1 pathway. Science. 2016 Jan 1;351(6268):53-8. doi: 10.1126/science.aad2087. Epub 2015 Nov 19.
PubMed 26586190Peng H, Wang Y, Luo W. Multifaceted role of branched-chain amino acid metabolism in cancer. Oncogene. 2020 Oct;39(44):6747-6756. doi: 10.1038/s41388-020-01480-z. Epub 2020 Sep 25.
PubMed 32978521Bigger CH, Braymer HD. Neurospora crassa invertase. A study of amino acids at the active center. Biochim Biophys Acta. 1975 Aug 26;397(2):418-27. doi: 10.1016/0005-2744(75)90131-x.
PubMed 239750Saygin C, Carraway HE. Emerging therapies for acute myeloid leukemia. J Hematol Oncol. 2017 Apr 18;10(1):93. doi: 10.1186/s13045-017-0463-6.
PubMed 28420416Auslander N, Yizhak K, Weinstock A, Budhu A, Tang W, Wang XW, Ambs S, Ruppin E. A joint analysis of transcriptomic and metabolomic data uncovers enhanced enzyme-metabolite coupling in breast cancer. Sci Rep. 2016 Jul 13;6:29662. doi: 10.1038/srep29662.
PubMed 27406679Li JT, Li KY, Su Y, Shen Y, Lei MZ, Zhang F, Yin M, Chen ZJ, Wen WY, Hu WG, Su D, Qu J, Lei QY. Diet high in branched-chain amino acid promotes PDAC development by USP1-mediated BCAT2 stabilization. Natl Sci Rev. 2021 Nov 26;9(5):nwab212. doi: 10.1093/nsr/nwab212. eCollection 2022 May.
PubMed 35663242Wang Z, Lu Z, Lin S, Xia J, Zhong Z, Xie Z, Xing Y, Qie J, Jiao M, Li Y, Wen H, Zhao P, Zhang D, Zhou P, Qian J, Luo F, Wang L, Yu H, Liu J, Gu J, Liu R, Chu Y. Leucine-tRNA-synthase-2-expressing B cells contribute to colorectal cancer immunoevasion. Immunity. 2022 Jun 14;55(6):1067-1081.e8. doi: 10.1016/j.immuni.2022.04.017. Epub 2022 Jun 3.
PubMed 35659337Silva LS, Poschet G, Nonnenmacher Y, Becker HM, Sapcariu S, Gaupel AC, Schlotter M, Wu Y, Kneisel N, Seiffert M, Hell R, Hiller K, Lichter P, Radlwimmer B. Branched-chain ketoacids secreted by glioblastoma cells via MCT1 modulate macrophage phenotype. EMBO Rep. 2017 Dec;18(12):2172-2185. doi: 10.15252/embr.201744154. Epub 2017 Oct 24.
PubMed 29066459Ikeda K, Kinoshita M, Kayama H, Nagamori S, Kongpracha P, Umemoto E, Okumura R, Kurakawa T, Murakami M, Mikami N, Shintani Y, Ueno S, Andou A, Ito M, Tsumura H, Yasutomo K, Ozono K, Takashima S, Sakaguchi S, Kanai Y, Takeda K. Slc3a2 Mediates Branched-Chain Amino-Acid-Dependent Maintenance of Regulatory T Cells. Cell Rep. 2017 Nov 14;21(7):1824-1838. doi: 10.1016/j.celrep.2017.10.082.
PubMed 29141216Chirmule NB, Chaturvedi RM, Deo MG. Immunogenic "subunit" of the ICRC antileprosy vaccine. Int J Lepr Other Mycobact Dis. 1988 Mar;56(1):27-35.
PubMed 3131465Collard WM. Diagnosing earache in infants and small children. S Afr Med J. 1985 Dec 21;68(13):916. No abstract available.
PubMed 4081922
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single-Center, 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
- ClinicalTrials.gov ID
- NCT07586891
- Acronym / sponsor ID
- XJPF-LCY-V202511
- Conditions
- Melanoma (Skin Cancer)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard diet，anti-PD-1 and other essential drugs |
| Experimental Group | Experimental | Dietary Supplement: Low Branched-Chain Amino Acid DietLow BCAA diet, anti-PD-1 and other essential drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 age on the day of signing the consent form.
Key exclusion criteria (12 listed)
- The patient is currently participating, or has participated in a clinical trial of an investigational drug or medical device within 4 weeks prior to the first dose of the study drug.
- The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.
- The patient has received systemic corticosteroid therapy (>10 mg/kg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive therapy.
- The patient has a known history of hematologic malignancies, primary brain tumors, sarcoma, or other primary solid tumors, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- The patient has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Branched-Chain Amino Acid DietThe experimental group receives a low branched-chain amino acid diet | Dietary supplement | Experimental Group |
Primary outcome
Systolic blood pressure
Time frame: through study completion, an average of 3 months
Systolic blood pressure
respiratory rate
Time frame: through study completion, an average of 3 months
respiratory rate
body temperature
Time frame: through study completion, an average of 3 months
body temperature
heart rate
Time frame: through study completion, an average of 3 months
heart rate
Left ventricular ejection fraction (LVEF)
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
LVEF assessed by echocardiography.
Hemoglobin concentration
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Hemoglobin concentration assessed by complete blood count
White blood cell count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
White blood cell count assessed by complete blood count
Platelet count
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Platelet count assessed by complete blood count
Alanine aminotransferase (ALT) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
ALT level measured from clinical biochemistry panel
Aspartate aminotransferase (AST) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
AST level measured from clinical biochemistry panel
Creatinine level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Creatinine level measured from clinical biochemistry panel
Blood glucose level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Blood glucose level measured from clinical biochemistry panel (fasting or as specified in protocol)
Lactate dehydrogenase (LDH) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
LDH level measured from clinical biochemistry panel
Triiodothyronine (T3) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
T3 level measured from blood sample.
Thyroid-stimulating hormone (TSH) level
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
TSH level measured from blood sample.
Left ventricular end-diastolic diameter (LVEDD)
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
LVEDD assessed by echocardiography
Cardiac output
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
Cardiac output estimated by echocardiography
PR interval
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
PR interval assessed by 12-lead electrocardiography
QRS duration
Time frame: Baseline and every 8 weeks through study completion (up to 3 months)
QRS duration assessed by 12-lead electrocardiography
2 secondary outcomes
Lymph node target lesion short-axis diameter
Time frame: Baseline and every 3 weeks through study completion (up to 3 months)
Percentage of residual viable tumor cells in lymph nodes
Time frame: Perioperative (after 3 months of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 21639810Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.
- Results publication: PubMed 31084571Biswas D, Duffley L, Pulinilkunnil T. Role of branched-chain amino acid-catabolizing enzymes in intertissue signaling, metabolic remodeling, and energy homeostasis. FASEB J. 2019 Aug;33(8):8711-8731. doi: 10.1096/fj.201802842RR. Epub 2019 May 14.
- Results publication: PubMed 29368944Tedesco L, Corsetti G, Ruocco C, Ragni M, Rossi F, Carruba MO, Valerio A, Nisoli E. A specific amino acid formula prevents alcoholic liver disease in rodents. Am J Physiol Gastrointest Liver Physiol. 2018 May 1;314(5):G566-G582. doi: 10.1152/ajpgi.00231.2017. Epub 2018 Jan 25.
- Results publication: PubMed 20682696Saha AK, Xu XJ, Lawson E, Deoliveira R, Brandon AE, Kraegen EW, Ruderman NB. Downregulation of AMPK accompanies leucine- and glucose-induced increases in protein synthesis and insulin resistance in rat skeletal muscle. Diabetes. 2010 Oct;59(10):2426-34. doi: 10.2337/db09-1870. Epub 2010 Aug 3.
- Results publication: PubMed 26586190Saxton RA, Knockenhauer KE, Wolfson RL, Chantranupong L, Pacold ME, Wang T, Schwartz TU, Sabatini DM. Structural basis for leucine sensing by the Sestrin2-mTORC1 pathway. Science. 2016 Jan 1;351(6268):53-8. doi: 10.1126/science.aad2087. Epub 2015 Nov 19.
- Results publication: PubMed 32978521Peng H, Wang Y, Luo W. Multifaceted role of branched-chain amino acid metabolism in cancer. Oncogene. 2020 Oct;39(44):6747-6756. doi: 10.1038/s41388-020-01480-z. Epub 2020 Sep 25.
- Results publication: PubMed 239750Bigger CH, Braymer HD. Neurospora crassa invertase. A study of amino acids at the active center. Biochim Biophys Acta. 1975 Aug 26;397(2):418-27. doi: 10.1016/0005-2744(75)90131-x.
- Results publication: PubMed 28420416Saygin C, Carraway HE. Emerging therapies for acute myeloid leukemia. J Hematol Oncol. 2017 Apr 18;10(1):93. doi: 10.1186/s13045-017-0463-6.
- Results publication: PubMed 27406679Auslander N, Yizhak K, Weinstock A, Budhu A, Tang W, Wang XW, Ambs S, Ruppin E. A joint analysis of transcriptomic and metabolomic data uncovers enhanced enzyme-metabolite coupling in breast cancer. Sci Rep. 2016 Jul 13;6:29662. doi: 10.1038/srep29662.
- Results publication: PubMed 35663242Li JT, Li KY, Su Y, Shen Y, Lei MZ, Zhang F, Yin M, Chen ZJ, Wen WY, Hu WG, Su D, Qu J, Lei QY. Diet high in branched-chain amino acid promotes PDAC development by USP1-mediated BCAT2 stabilization. Natl Sci Rev. 2021 Nov 26;9(5):nwab212. doi: 10.1093/nsr/nwab212. eCollection 2022 May.
- Results publication: PubMed 35659337Wang Z, Lu Z, Lin S, Xia J, Zhong Z, Xie Z, Xing Y, Qie J, Jiao M, Li Y, Wen H, Zhao P, Zhang D, Zhou P, Qian J, Luo F, Wang L, Yu H, Liu J, Gu J, Liu R, Chu Y. Leucine-tRNA-synthase-2-expressing B cells contribute to colorectal cancer immunoevasion. Immunity. 2022 Jun 14;55(6):1067-1081.e8. doi: 10.1016/j.immuni.2022.04.017. Epub 2022 Jun 3.
- Results publication: PubMed 29066459Silva LS, Poschet G, Nonnenmacher Y, Becker HM, Sapcariu S, Gaupel AC, Schlotter M, Wu Y, Kneisel N, Seiffert M, Hell R, Hiller K, Lichter P, Radlwimmer B. Branched-chain ketoacids secreted by glioblastoma cells via MCT1 modulate macrophage phenotype. EMBO Rep. 2017 Dec;18(12):2172-2185. doi: 10.15252/embr.201744154. Epub 2017 Oct 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Branched-Chain Amino Acid Diet in people with Melanoma (Skin Cancer), run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weinan Guo (+ 86-29-84775406, guown@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: through study completion, an average of 3 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07586891, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.