AzTrials
AzTrials

Gastric CancerPhase 1LUCENT-GC-01NCT07488312

Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer

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

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objectives of this study is o evaluate the safety of a leucine-restricted diet in patients with gastric cancer and determine the impact of a leucine-restricted diet on serum amino acid concentrations in patients with gastric cancer.Besides,we can assess changes in the immune microenvironment of gastric… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
Leucine-restricted diet.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
1 Oct 2025to 1 Dec 2026
Phase
Phase 1
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

  • Pathologically confirmed gastric carcinoma requiring preoperative endoscopic localization marking or delineation of the lesion extent.
  • Aged between 18 and 70 years, regardless of gender.
  • Ability to consume oral or nasogastric tube feeding of a liquid diet.
  • Provision of signed informed consent and voluntary participation in this study.
  • No evidence of distant metastasis on preoperative imaging studies (e.g., CT, PET-CT), and deemed suitable for surgical resection.
  • No concurrent diagnosis of other active malignancies.

Who cannot join

  • Presence of cognitive impairment or psychological disorders that may compromise the understanding of the research content.
  • Diagnosis of Type I or Type II Diabetes Mellitus.
  • Severe diarrhea, intractable vomiting, severe malabsorption syndromes, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding.
  • Known allergy to the primary components of the leucine-deficient nutritional formula.
  • Concurrent use of other nutritional supplements that may interfere with the trial's efficacy.
  • Postoperative pathological diagnosis confirming non-primary gastric cancer.

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
  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer

The primary objectives of this study is o evaluate the safety of a leucine-restricted diet in patients with gastric cancer and determine the impact of a leucine-restricted diet on serum amino acid concentrations in patients with gastric cancer.Besides,we can assess changes in the immune microenvironment of gastric cancer patients following administration of a leucine-restricted diet and observe alterations in body composition of gastric cancer patients after the application of a leucine-restricted diet.

Conditions
Gastric Cancer
Being tested
Leucine-restricted diet.
Keywords
Leucine-Restricted Diet, Gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Leucine-restricted diet.Dietary supplement

    During the preoperative waiting period after hospital admission, study participants received a leucine-restricted diet for three days prior to surgery. Surgical intervention was performed immediately following the 3-day dietary intervention. Postoperatively, patients gradually resumed a regular diet according to standard surgical protocols.

Study groups in NCT07488312
Study groupRoleWhat they receive
Experimental GroupExperimentalDuring the preoperative waiting period after hospital admission, study participants received a leucine-restricted diet for three days prior to surgery. Surgical intervention was performed immediately following the 3-day dietary intervention. Postoperatively, patients gradually resumed a regular diet according to standard surgical protocols.
Receives: Dietary Supplement: Leucine-restricted diet.

What is being measured

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

  1. Amino acid concentration

    Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine

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

  2. The adverse event of leucine-restricted diet in patients with gastric cancer

    This indicator was assessed using the Common Terminology Criteria for Adverse Event(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 surgery

Secondary outcomes (1)
  1. CD8+ T cell percentage

    Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of CD8+ T cell percentage.

    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 posted23 Mar 2026
  2. Study start1 Oct 2025
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488312
Sponsor's protocol ID
KYLL-2025-07-007-1
Acronym
LUCENT-GC-01
Status last verified
Jan 2026
First submitted
17 Mar 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available.

    PubMed 35914639
  • Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.

    PubMed 33946039
  • Powell JD, Pollizzi KN, Heikamp EB, Horton MR. Regulation of immune responses by mTOR. Annu Rev Immunol. 2012;30:39-68. doi: 10.1146/annurev-immunol-020711-075024. Epub 2011 Nov 29.

    PubMed 22136167
  • 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 1 study testing Leucine-restricted diet. in people with 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 6 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: enrolling by invitation, as of the sponsor's last update on 20 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amino acid concentration (time frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation). The study lists 2 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 NCT07488312, 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 20 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in