Stomach Cancer Clinical Trials

Find Stomach Cancer Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Hui Qu, Doctor of Medicine
doctorquhui@email.sdu.edu.cn
+86-18560085120
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 108
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials