RecruitingPhase 2NCT07212933

The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial

Sponsor

Chinese PLA General Hospital

Enrollment

90 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric (Stomach) Cancer Immunotherapy Biological Therapy

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immune cell therapy called RAK cell therapy for people with advanced (stage IV) stomach cancer or cancer of the junction between the stomach and esophagus who have already tried standard treatments without success. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with stage IV stomach or gastroesophageal junction cancer confirmed by biopsy or imaging - Your cancer has progressed or stopped responding to at least one prior treatment (such as chemotherapy, targeted therapy, or immunotherapy) - You have measurable tumor(s) that can be tracked on scans - You are reasonably functional (able to do some daily activities) - Your expected survival is at least 1 month **You may NOT be eligible if...** - You have another type of active cancer - You have severe heart, lung, or brain disease - Your blood counts, liver, kidney, or clotting function are significantly impaired - Your expected survival is less than 1 month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRetroNectin active Killer cells

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.

DRUGTAS-102 (trifluridine and tipiracil, Lonsurf®)

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.