Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer (LUCENT-GC-02)

April 15, 2026 updated by: Qilu Hospital of Shandong University

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

Consistent with previous literature, the investigators postulate that a leucine-restricted diet is safe and well-tolerated in gastric cancer patients receiving neoadjuvant chemo-immunotherapy. Furthermore, the investigators propose that this dietary regimen promotes the activation of immune cells within the tumor microenvironment (TME). When combined with neoadjuvant chemo-immunotherapy, it demonstrates synergistic anti-tumor efficacy, thereby improving patient prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, participants were divided into an intervention group and a control group. Both groups received four cycles of neoadjuvant therapy comprising Oxaliplatin, S-1, and the PD-1 inhibitor Sintilimab. The intervention group implemented a 3-day leucine-restricted diet during each cycle, gradually resuming a normal diet thereafter, whereas the control group maintained a standard normal diet throughout the treatment period. This design was established to evaluate the safety and efficacy of the leucine-restricted diet in the context of neoadjuvant chemo-immunotherapy for gastric cancer.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathological Confirmation: Histologically confirmed locally advanced gastric cancer.
  • Demographics: Aged 18 to 70 years, inclusive, regardless of gender.
  • Dietary Capability: Capable of oral intake or receiving a liquid diet via nasogastric tube.
  • Consent: Willing to participate in the study and have signed the Written Informed Consent Form (ICF).
  • Staging and Treatment Indication: No evidence of distant metastasis on imaging examinations (such as CT or PET-CT), with a clinical stage of locally advanced gastric cancer, indicating the need for neoadjuvant chemo-immunotherapy prior to surgery.
  • Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer.

Exclusion Criteria:

  • Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders severe enough to 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/Hypersensitivity: 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 the evaluation of efficacy.
  • Treatment Tolerance: Inability to tolerate neoadjuvant chemo-immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.
  • Pathological Diagnosis: Postoperative pathological diagnosis confirming non-primary gastric cancer (e.g., metastatic tumors from other origins).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leucine-restricted Group
Patients received four cycles of neoadjuvant therapy consisting of chemotherapy (Oxaliplatin plus S-1) combined with the PD-1 inhibitor Sintilimab. During each cycle, patients adhered to a leucine-restricted diet for 3 days. Following this 3-day period, the dietary intervention was discontinued, and patients gradually resumed a normal diet until the next cycle.
Dietary supplement: Leucine-restricted diet
Patients received a total of four cycles of neoadjuvant therapy.During each treatment cycle, patients adhered to a leucine-restricted diet for 3 days. After this 3-day period, the dietary intervention was stopped, and patients gradually resumed a normal diet for the remainder of the cycle.
No Intervention: Normal diet Group
Patients in the control group underwent four cycles of neoadjuvant chemo-immunotherapy (Oxaliplatin, S-1, and Sintilimab) but adhered to a conventional normal diet throughout the entire treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Evaluation Criteria in Solid Tumors (RECIST) Grade
Time Frame: 1 year after surgery
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.
1 year after surgery
1-year survival rate and overall survival (OS)
Time Frame: 1 year after surgery
This indicator is calculated by comprehensively summarizing the 1-year survival rate and overall survival.
1 year after surgery
The tumor regression grade (TRG) system
Time Frame: 1 month after surgery
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.
1 month after surgery
Grade of CTCAE grading system
Time Frame: 6 months after surgery
The CTCAE grading system comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum amino acid concentrations in patients
Time Frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.
Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine.
Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.
Changes in the Immune Microenvironment
Time Frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation
Tumor single-cell RNA sequencing (scRNA-seq) and circulating tumor DNA (ctDNA) data were compared before and after the dietary intervention. Additionally, peripheral blood samples were collected for flow cytometric analysis of CD8+ T cells and ctDNA quantification.
Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202509-010-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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