Actively Recruiting
The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
Led by Chinese PLA General Hospital · Updated on 2025-10-08
90
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and survival outcomes of human umbilical cord blood RetroNectin-Activated Killer (RAK) cells in patients with advanced gastric cancer that has recurred or spread after frontline therapy has failed. This Phase 2 randomized controlled trial aims to determine the maximum tolerated dose of RAK cell therapy and compare overall survival, progression-free survival, and adverse events between patients receiving RAK cells combined with TAS-102 and those receiving TAS-102 alone. The study is designed to provide foundational evidence for larger future clinical studies in this patient population. Participants are randomly assigned to one of two groups: one receiving combined therapy of RAK cells and the drug TAS-102, and the other receiving TAS-102 alone. TAS-102 is taken orally at a dose of 35 mg/m² twice daily on Days 1-5 of each 3-week cycle. RAK cells are derived from the patient's own immune cells and activated to target tumor cells with minimal harm to normal cells. The trial includes a dose-escalation phase to find the highest safe dose of RAK cell therapy. During the study, participants undergo tumor assessments using CT or MRI scans, physical performance evaluations, and monitoring for side effects. Researchers will track progression-free survival over one year as the primary outcome, along with overall survival, objective response rate, and time to progression. The study includes regular evaluations to assess safety and treatment effects, with participant involvement lasting throughout the treatment cycles and follow-up assessments as scheduled by the trial protocol.
CONDITIONS
Brief Title
The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily join this study and sign the informed consent form.
- Age 18 years and up to 70 years.
- Confirmed Stage IV gastric cancer or gastroesophageal junction adenocarcinoma by gastroscopic pathology or imaging.
- Disease progression or failure after prior frontline anti-tumor therapy.
- Measurable solid tumors with tumor assessment by CT scan or MRI within 28 days before treatment.
- Physical performance status ECOG 0-3.
- Expected lifespan of at least 1 month.
- Ability to understand the study procedures and provide written informed consent.
You will not qualify if you...
- Concurrent other types of malignancy.
- Severe cardiac, pulmonary, or cerebral system diseases.
- Expected survival less than 1 month.
- Moderate to severe bone marrow suppression (HGB <80 g/L; WBC <2.0×10⁹/L; ANC <1.0×10⁹/L; PLT <50×10⁹/L).
- Significantly decreased liver function (Child-Pugh Grade C).
- Severe renal insufficiency (CKD Stage III and above).
- Severe coagulation dysfunction (INR ≥1.5 or APTT >1.5 × ULN).
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive TAS-102 orally on Days 1-5 of each 3-week cycle. Participants in the experimental arm also receive RetroNectin-Activated Killer (RAK) cell therapy derived from their own blood cells to target tumor cells.
Visits occur with each treatment cycle, at least once every 3 weeks
Trial Site Locations
Total: 1 location
1
The First＆Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
H
HongYi Liu, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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