The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese PLA General Hospital
About this trial
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 criteria
Qualifiers
1. Subjects voluntarily join this study and sign the informed consent form. 2. Age ≥18 years and ≤70 years. 3. Confirmed by gastroscopic pathology or imaging (enhanced CT/PET-CT) as Stage IV gastric cancer or gastroesophageal junction adenocarcinoma (cTanyNanyM1). Metastatic sites include but are not limited to: liver, peritoneum, lungs, pancreas, greater omentum, retroperitoneal lymph nodes, etc.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- RetroNectin active Killer cells
- TAS-102 (trifluridine and tipiracil, Lonsurf®)
Treatment groups
90 Participants
are divided into 2 treatment groupsLocations
1The First＆Fifth Medical Center of Chinese PLA General Hospital100853, BeijingBeijing Municipality, China
Sponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
Source ClinicalTrials.gov