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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Participants voluntarily agree to join and sign informed consent.
- Age between 18 and 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.
- Presence of measurable solid tumors assessed by CT or MRI within 28 days before treatment.
- Physical performance status ECOG 0-3.
- Expected survival of at least 1 month.
- Ability to understand study procedures and provide written informed consent.
You will not qualify if you...
- Presence of other concurrent malignancies.
- Severe cardiac, pulmonary, or cerebral 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 or higher).
- Severe coagulation dysfunction (INR ≥1.5 or APTT >1.5 times upper limit of normal).
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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.
CONTACT
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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