Clinical Trial

Malic Acid Supplementation Combined With Immunotherapy in Patients With Solid Tumors

Not Yet Recruiting Early Phase 1
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Summary
This is a study on the safety and efficacy of malic acid supplementation combined with immunotherapy for anti-tumor treatment in patients with solid tumors. The primary study objective is to determine the oral safety of malic acid; Secondary study objectives: 1. To evaluate the preliminary efficacy of malic acid in the study population. 2. To determine the recommended phase 2 dose (RP2D) of oral malic acid. Exploratory endpoints: Immune indicators including white blood cell count, neutrophil, lymphocyte, monocyte, eosinophil and basophil (count/proportion); metabolic indicators including blood glucose, triglycerides; nutritional indicators including body weight.
Trial Details
NCT Number NCT07325123
Lead Sponsor The First Affiliated Hospital of Xinxiang Medical College
Conditions Solid Tumor Malignancies
Enrollment 30 participants
Start Date 2025-12-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-08