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

NCT07537361 | Recruiting Phase 2 DMC

• 1 other identifier: KYLL-202509-010-1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; Leucine-restricted Diet

Keywords

gastric cancer; leucine-restricted diet; Neoadjuvant Therapy; 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 surgery

• 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

  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 Outcomes (2)

• Serum amino acid concentrations in patients

  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

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

Study Arms (2)

Leucine-restricted Group

EXPERIMENTAL

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

Normal diet Group

NO INTERVENTION

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.

Interventions

Leucine-restricted diet DIETARY_SUPPLEMENT

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.

Leucine-restricted 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:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (12)

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MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 17, 2026
• First Posted: April 17, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)