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Safety and Efficacy of Combining a Vitamin B6-Limited Diet With Immunotherapy in Solid Tumor Patients: A Clinical Study Protocol

NCT07257497 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-02

No results posted yet for this study

Summary

This is a phase I single-arm clinical study conducted by West China Hospital of Sichuan University. The research duration is from October 2025 to June 2027, aiming to evaluate the safety and efficacy of vitamin B6-restricted (-VitB6 diet) in patients with solid tumors. A total of 20 patients with solid tumors, aged 18 - 75 years old, who meet specific inclusion criteria such as having at least one measurable lesion according to RECIST v1.1 criteria and an ECOG score of 0 - 1, will be enrolled.

Patients will receive -VitB6 diet intervention for 2 cycles (3 weeks per cycle) while continuing their original immunotherapy. The -VitB6 diet strictly limits vitamin B6 intake, and patients can only consume foods with extremely low vitamin B6 content. The research will collect data on patients' basic information, nutritional status, blood, immunity, and tumor imaging at baseline and during follow - up.

The primary endpoint of the study is the occurrence type, frequency, and severity of treatment-related adverse events (TEAE). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). Exploratory endpoints involve evaluating the nutritional adequacy of the -VitB6 diet, its impact on patients' quality of life, and its influence on amino acid metabolism and immune status in patients.

During the study, safety will be evaluated by closely monitoring adverse events according to NCI CTCAE (version 5.0), and efficacy will be assessed using RECIST 1.1 standard. Statistical analysis will be performed using SAS 9.4 software, including descriptive statistics for safety and efficacy data, and calculating confidence intervals for relevant indicators. This study hopes to provide new strategies and directions for the treatment of advanced solid tumors.

Conditions

  • Solid Tumor Cancer

Interventions

DIETARY_SUPPLEMENT

Vitamin B6-restricted diet + immunotherapy

Targeted Vitamin B6 Metabolism: The intervention zeroes in on Vitamin B6 metabolism. As solid tumors often have Vitamin B6 synthesis flaws and rely on external Vitamin B6, dietary restriction of Vitamin B6 is a novel approach. Dietary Intervention: The -vitB6 liquid diet in this study is precisely defined. Dosage is determined by patient weight, following 30 kcal/kg/day for energy and 1.5 g/kg/day for protein. A low -vitB6 food list is provided. Study Design and Endpoints: It's a Phase I single - arm study. Its main goal is to evaluate the safety and tolerance of the combined treatment. Secondary and exploratory endpoints cover efficacy, nutritional state, and immune status.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2027-06-01
Completion
2027-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257497 on ClinicalTrials.gov