Status:
RECRUITING
The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Gastric (Stomach) Cancer
Biological Therapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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.
- 4\. 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).
- 5\. 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.
- 6\. 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07212933
Start Date
July 1 2025
End Date
June 30 2028
Last Update
October 8 2025
Active Locations (1)
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1
The First＆Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853