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

NCT07537348 | Recruiting Phase 2 DMC

• 1 other identifier: KYLL-2025-10-003-1
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Advanced Gastric Cancer

Keywords

Advanced Gastric Cancer; Leucine-Restricted Diet; Chemotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

  1 year after therapy

• 1-year survival rate and overall survival (OS)

  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

  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

  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.

  6 months after therapy

Secondary Outcomes (2)

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

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

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

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

Study Arms (1)

Leucine-restricted diet group

EXPERIMENTAL

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.

Dietary Supplement: Lucine-restricted diet

Interventions

Lucine-restricted diet DIETARY_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.

Leucine-restricted diet group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (13)

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Central Study Contacts

Hui Qu, Doctor of Medicine

CONTACT

+86-18560085120; doctorquhui@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 17, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)