This project employs a prospective, double-blind, randomized controlled trial methodology to comparatively analyze the safety and survival outcomes of human umbilical cord blood RAK cells applied in advanced gastric cancer. Firstly, the maximum tolerated dose (MTD) of RAK cell therapy for patients with advanced gastric cancer will be determined through a dose-escalation trial. Subsequently, the overall survival (OS), progression-free survival (PFS), and incidence of adverse events will be compared between the RAK treatment group and the control group. This aims to explore the efficacy and safety of biotherapy for recurrent or metastatic gastric cancer where frontline therapy has failed, thereby laying the foundation and providing evidence for large-scale, multi-center clinical studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
RetroNectin-Activated Killer (RAK) cells, derived from autologous peripheral blood mononuclear cells (PBMCs), are induced in vitro by RetroNectin along with anti-CD3 monoclonal antibody and Interleukin-2 (IL-2). These cells consist of various cytotoxic effectors, primarily CD8+ T (cytotoxic T, Tc) cells and natural killer T cells, which exhibit minimal cytotoxicity to normal cells but substantial specificity to tumor cells, thereby demonstrating both safety and potent anti-tumor activity.
Based on the results of the RECOURSE \[16\] and TERRA \[17\] studies, TAS-102 (Trifluridine/Tipiracil Hydrochloride) will be administered orally at a dose of 35mg/m², twice daily, Days 1-5, with each cycle lasting 3 weeks.
The First&Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival
Progression-Free Survival (PFS) is the length of time during and after treatment that a patient's cancer does not get worse. It measures how long the disease remains stable or in remission.
Time frame: one-year
Overall Survival
from a defined randomization until death from any cause.
Time frame: one-year
Objective Response Rate (ORR)
the proportion of patients in a clinical trial whose cancer shrinks (responds) by a predefined amount for a minimum period of time. It is a direct measure of a drug's anti-tumor activity.
Time frame: one-year
Time to Progression (TTP)
the length of time from the start of treatment (or randomization in a trial) until the patient's cancer is objectively documented to have worsened.
Time frame: one-year
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