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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

• Response Evaluation Criteria in Solid Tumors (RECIST) Grade [Срок оценки: 1 year after surgery]
• 1-year survival rate and overall survival (OS) [Срок оценки: 1 year after surgery]
• The tumor regression grade (TRG) system [Срок оценки: 1 month after surgery]
• Grade of CTCAE grading system [Срок оценки: 6 months after surgery]

Вторичные конечные точки (2)

• Serum amino acid concentrations in patients [Срок оценки: 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 [Срок оценки: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Публикации

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Идентификаторы

NCT: NCT07537361 · KYLL-202509-010-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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