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

Recruiting now · Phase 2

Conditions studied: Gastric (Stomach) Cancer, Biological Therapy, Immunotherapy

In brief

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.

Key facts

Study ID

NCT07212933

Run by

Chinese PLA General Hospital

People needed

90

Starts

2025-07-01

Expected to finish

2028-06-30

Last updated by the study team

2025-10-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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).
• Have measurable solid tumors (efficacy evaluation standard: RECIST 1.1); tumor assessment via CT scan or MRI must be performed within 28 days before treatment.
• Physical performance status ECOG 0-3. 7. Expected lifespan ≥1 month. 8. Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

You may not qualify if…

• 1. Concurrent other types of malignancy. 2. Severe cardiac, pulmonary, or cerebral system diseases. 3. Expected survival <1 month. 4. Laboratory investigations indicating unsuitability for receiving anti-tumor biotherapy:
• 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).

Where it is running

• The First＆Fifth Medical Center of Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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