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Advanced Gastric CancerPhase 2LUCENT-GC-03NCT07537348

Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherapy in Advanced Gastric Cancer

A Phase 2 study testing Lucine-restricted diet in people with Advanced Gastric Cancer, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Based on existing literature, we posit that a leucine-restricted diet is safe and well-tolerated in patients with advanced gastric cancer receiving combined chemotherapy and immunotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Lucine-restricted diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteChina
Study dates
1 Jan 2026to 31 Dec 2028
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis and Treatment Plan: Patients with advanced gastric cancer with distant metastasis, confirmed by imaging modalities (such as CT or PET-CT) and clinical pathological data, who are indicated for combined chemotherapy and immunotherapy.
  • Demographics: Aged 18 to 70 years, regardless of gender.
  • Dietary Capability: Capable of oral intake or receiving liquid diet via nasogastric tube.
  • Consent: Willing to participate in this study and have signed the Informed Consent Form (ICF).
  • Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer.

Who cannot join

  • Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders that prevent the patient from understanding the study content or providing informed consent.
  • Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Gastrointestinal Conditions: Presence of severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding.
  • Allergy：Known hypersensitivity or allergy to any of the main components of the leucine-deficient nutritional powder.
  • Concomitant Supplements: Current use of other nutritional supplements that may potentially confound the study results or affect efficacy evaluation.
  • Treatment Tolerance: Inability to tolerate combined chemotherapy and immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Qu, Doctor of Medicine contact

+86-18560085120

doctorquhui@email.sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Hui Qu, Doctor of Medicine, +86-18560085120, doctorquhui@email.sdu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Chemotherapy and Immunotherapy

Based on existing literature, we posit that a leucine-restricted diet is safe and well-tolerated in patients with advanced gastric cancer receiving combined chemotherapy and immunotherapy. Patients adhering to this dietary regimen exhibit a significant reduction in serum leucine concentrations, with no notable impact on the serum levels of other amino acids. Furthermore, leucine restriction promotes the activation of immune cells within the tumor microenvironment. When applied in conjunction with chemotherapy and immunotherapy for advanced gastric cancer, this approach demonstrates synergistic anti-tumor efficacy. It is expected to enhance tumor response rates , improve the 1-year survival rate, prolong overall survival (OS), and ultimately optimize patient prognosis.

Read the detailed description

This study employs a self-controlled design to comprehensively evaluate the safety and efficacy of a leucine-restricted diet combined with chemotherapy and immunotherapy in patients with advanced gastric cancer, with follow-up assessments of survival status to determine the 1-year survival rate and Overall Survival (OS). For patients eligible for R0 resection, anti-tumor efficacy will be pathologically assessed using the Tumor Regression Grade system, alongside statistical analysis of tumor response rates following combined therapy. Furthermore, the study will investigate mechanistic changes by comparing the tumor immune microenvironment and serum amino acid profiles (including leucine) before and after dietary intervention, while monitoring alterations in patient body composition, ultimately aiming to validate the hypothesis that leucine restriction enhances therapeutic outcomes in this setting.

Being tested
Lucine-restricted diet
Keywords
Advanced Gastric Cancer, Leucine-Restricted Diet, Chemotherapy, Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lucine-restricted dietDietary supplement

    During each hospitalization cycle for combined chemotherapy and immunotherapy, study participants will undergo a 3-day leucine-restricted diet concurrently with PD-1 inhibitor and chemotherapy administration; following this 3-day intervention period, the dietary restriction will be discontinued, and patients will gradually resume a normal diet.

Study groups in NCT07537348
Study groupRoleWhat they receive
Leucine-restricted diet groupExperimentalDuring each hospitalization cycle for combined chemotherapy and immunotherapy, study participants will undergo a 3-day leucine-restricted diet concurrently with PD-1 inhibitor and chemotherapy administration; following this 3-day intervention period, the dietary restriction will be discontinued, and patients will gradually resume a normal diet.
Receives: Dietary Supplement: Lucine-restricted diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Evaluation Criteria in Solid Tumors (RECIST) Grade

    This scoring system includes four grades: CR, PR, PD, and SD, where CR stands for complete response, PR for partial response, PD for progressive disease, and SD for stable disease.

    Measured: 1 year after therapy

  2. 1-year survival rate and overall survival (OS)

    This indicator is calculated by comprehensively summarizing the 1-year survival rate and overall survival.

    Measured: 1 year after surgery

  3. The tumor regression grade (TRG) system

    TRG (Tumor Regression Grade) is used to assess pathological response after neoadjuvant therapy based on the 8th edition AJCC/CAP criteria. Different grades represent varying degrees of regression: TRG 0 indicates complete response (no residual tumor cells); TRG 1 indicates near-complete response (scattered residual tumor cells, <10%); TRG 2 indicates partial response (residual tumor cells accounting for 10%-50%); TRG 3 indicates no or minimal response (residual tumor cells >50%). Higher grades suggest poorer treatment efficacy.

    Measured: 1 month after surgery

  4. Grade of CTCAE grading system

    This indicator was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) grading system, which comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death.

    Measured: 6 months after therapy

Secondary outcomes (2)

  1. Changes in the Immune Microenvironment of Gastric Cancer Patients Following a Leucine-Restricted Diet

    Comparative analysis of tumor scRNA-seq and ctDNA profiles pre- and post-diet, alongside flow cytometry-based assessment of circulating CD8+ T cells and ctDNA levels in blood samples.

    Measured: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.

  2. Serum concentrations of various amino acids, including leucine, in patients with gastric cancer

    Peripheral blood was collected for the determination of amino acid concentrations.

    Measured: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start1 Jan 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07537348
Sponsor's protocol ID
KYLL-2025-10-003-1
Acronym
LUCENT-GC-03
Status last verified
Feb 2026
First submitted
17 Mar 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

    PubMed 34102137

  • Delgoffe GM, Powell JD. mTOR: taking cues from the immune microenvironment. Immunology. 2009 Aug;127(4):459-65. doi: 10.1111/j.1365-2567.2009.03125.x.

    PubMed 19604300

  • Araki K, Ellebedy AH, Ahmed R. TOR in the immune system. Curr Opin Cell Biol. 2011 Dec;23(6):707-15. doi: 10.1016/j.ceb.2011.08.006. Epub 2011 Sep 16.

    PubMed 21925855

  • Passarelli MC, Pinzaru AM, Asgharian H, Liberti MV, Heissel S, Molina H, Goodarzi H, Tavazoie SF. Leucyl-tRNA synthetase is a tumour suppressor in breast cancer and regulates codon-dependent translation dynamics. Nat Cell Biol. 2022 Mar;24(3):307-315. doi: 10.1038/s41556-022-00856-5. Epub 2022 Mar 14.

    PubMed 35288656

  • Saito Y, Li L, Coyaud E, Luna A, Sander C, Raught B, Asara JM, Brown M, Muthuswamy SK. LLGL2 rescues nutrient stress by promoting leucine uptake in ER+ breast cancer. Nature. 2019 May;569(7755):275-279. doi: 10.1038/s41586-019-1126-2. Epub 2019 Apr 17.

    PubMed 30996345

  • Wang N, Lu S, Cao Z, Li H, Xu J, Zhou Q, Yin H, Qian Q, Zhang X, Tao M, Jiang Q, Zhou P, Zheng L, Han L, Li H, Yin L, Gu Y, Dou X, Sun H, Wang W, Piao HL, Li F, Xu Y, Yang W, Chen S, Liu J. Pyruvate metabolism enzyme DLAT promotes tumorigenesis by suppressing leucine catabolism. Cell Metab. 2025 Jun 3;37(6):1381-1399.e9. doi: 10.1016/j.cmet.2025.02.008. Epub 2025 Mar 19.

    PubMed 40112809

  • Wang 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 35659337

  • Tong H, Jiang Z, Song L, Tan K, Yin X, He C, Huang J, Li X, Jing X, Yun H, Li G, Zhao Y, Kang Q, Wei Y, Li R, Long Z, Yin J, Luo Q, Liang X, Wan Y, Zheng A, Lin N, Zhang T, Xu J, Yang X, Jiang Y, Li Y, Xiang Y, Zhang Y, Feng L, Lei Z, Shi H, Ma X. Dual impacts of serine/glycine-free diet in enhancing antitumor immunity and promoting evasion via PD-L1 lactylation. Cell Metab. 2024 Dec 3;36(12):2493-2510.e9. doi: 10.1016/j.cmet.2024.10.019. Epub 2024 Nov 21.

    PubMed 39577415

  • Gao X, Sanderson SM, Dai Z, Reid MA, Cooper DE, Lu M, Richie JP Jr, Ciccarella A, Calcagnotto A, Mikhael PG, Mentch SJ, Liu J, Ables G, Kirsch DG, Hsu DS, Nichenametla SN, Locasale JW. Dietary methionine influences therapy in mouse cancer models and alters human metabolism. Nature. 2019 Aug;572(7769):397-401. doi: 10.1038/s41586-019-1437-3. Epub 2019 Jul 31.

    PubMed 31367041

  • Thandapani P, Kloetgen A, Witkowski MT, Glytsou C, Lee AK, Wang E, Wang J, LeBoeuf SE, Avrampou K, Papagiannakopoulos T, Tsirigos A, Aifantis I. Valine tRNA levels and availability regulate complex I assembly in leukaemia. Nature. 2022 Jan;601(7893):428-433. doi: 10.1038/s41586-021-04244-1. Epub 2021 Dec 22.

    PubMed 34937946

  • Jin J, Meng T, Yu Y, Wu S, Jiao CC, Song S, Li YX, Zhang Y, Zhao YY, Li X, Wang Z, Liu YF, Huang R, Qin J, Chen Y, Cao H, Tan X, Ge X, Jiang C, Xue J, Yuan J, Wu D, Wu W, Jiang CZ, Wang P. Human HDAC6 senses valine abundancy to regulate DNA damage. Nature. 2025 Jan;637(8044):215-223. doi: 10.1038/s41586-024-08248-5. Epub 2024 Nov 20.

    PubMed 39567688

  • Anderson E, LeVee A, Kim S, Atkins K, Guan M, Placencio-Hickok V, Moshayedi N, Hendifar A, Osipov A, Gangi A, Burch M, Waters K, Cho M, Klempner S, Chao J, Kamrava M, Gong J. A Comparison of Clinicopathologic Outcomes Across Neoadjuvant and Adjuvant Treatment Modalities in Resectable Gastric Cancer. JAMA Netw Open. 2021 Dec 1;4(12):e2138432. doi: 10.1001/jamanetworkopen.2021.38432.

    PubMed 34889947

  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

    PubMed 38572751

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lucine-restricted diet in people with Advanced Gastric Cancer, run by Qilu Hospital of Shandong University 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 5 inclusion and 6 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 17 Apr 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hui Qu, Doctor of Medicine (+86-18560085120, doctorquhui@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Evaluation Criteria in Solid Tumors (RECIST) Grade (time frame: 1 year after therapy). The study lists 4 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 NCT07537348, which also lists 13 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 17 Apr 2026.

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