OncoMatch/Clinical Trials/NCT07212933
The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
Is NCT07212933 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including RetroNectin active Killer cells and TAS-102 (trifluridine and tipiracil, Lonsurf®) for gastric (stomach) cancer.
Treatment: RetroNectin active Killer cells · TAS-102 (trifluridine and tipiracil, Lonsurf®) — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: chemotherapy — first- and second-line for advanced gastric cancer
Failure or disease progression after prior frontline anti-tumor therapy (including ineffective first- and second-line chemotherapy, targeted therapy, and immunotherapy for advanced gastric cancer)
Must have received: targeted therapy — first- and second-line for advanced gastric cancer
Failure or disease progression after prior frontline anti-tumor therapy (including ineffective first- and second-line chemotherapy, targeted therapy, and immunotherapy for advanced gastric cancer)
Must have received: immunotherapy — first- and second-line for advanced gastric cancer
Failure or disease progression after prior frontline anti-tumor therapy (including ineffective first- and second-line chemotherapy, targeted therapy, and immunotherapy for advanced gastric cancer)
Lab requirements
Blood counts
Moderate to severe bone marrow suppression: (HGB <80 g/L; WBC <2.0×10⁹/L; ANC <1.0×10⁹/L; PLT <50×10⁹/L) excluded
Kidney function
Severe renal insufficiency (CKD Stage III and above) excluded
Liver function
Significantly decreased liver function (Child-Pugh Grade C) excluded
Cardiac function
Severe cardiac disease excluded
Laboratory investigations indicating unsuitability for receiving anti-tumor biotherapy: 1. Moderate to severe bone marrow suppression: (HGB <80 g/L; WBC <2.0×10⁹/L; ANC <1.0×10⁹/L; PLT <50×10⁹/L). 2. Significantly decreased liver function (Child-Pugh Grade C). 3. Severe renal insufficiency (CKD Stage III and above). 4. Severe coagulation dysfunction (INR ≥1.5 or APTT >1.5 × ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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