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

Not Applicable

Recruiting

• Conditions: Gastric (Stomach) Cancer; Biological Therapy; Immunotherapy
• Interventions: Biological: RetroNectin active Killer cells; Drug: TAS-102 (trifluridine and tipiracil, Lonsurf®)

• Registration Number: NCT07212933
• Lead Sponsor: Chinese PLA General Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-01
• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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 Criteria

• 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:

  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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAS-102+RAK cell	RetroNectin active Killer cells	Combined therapy of RAK cells and TAS-102
TAS-102+RAK cell	TAS-102 (trifluridine and tipiracil, Lonsurf®)	Combined therapy of RAK cells and TAS-102
TAS-102	TAS-102 (trifluridine and tipiracil, Lonsurf®)	sole use of TAS-102

Primary Outcome Measures

Name	Time	Method
Progression-free survival	one-year	Progression-Free Survival (PFS) is the length of time during and after treatment that a patient's cancer does not get worse. It measures how long the disease remains stable or in remission.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	one-year	from a defined randomization until death from any cause.
Objective Response Rate (ORR)	one-year	the proportion of patients in a clinical trial whose cancer shrinks (responds) by a predefined amount for a minimum period of time. It is a direct measure of a drug's anti-tumor activity.
Time to Progression (TTP)	one-year	the length of time from the start of treatment (or randomization in a trial) until the patient's cancer is objectively documented to have worsened.

Trial Locations

Locations (1)

The First＆Fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing Municipality, China