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

NCT07212933 | Recruiting Phase 2 DMC

• 1 other identifier: S2025-443-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric (Stomach) Cancer; Biological Therapy; Immunotherapy

Keywords

Gastric cancer; late-stage; progression-free survival; chemotherapy; T cell biological therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

  one-year

Secondary Outcomes (3)

• Overall Survival

  one-year

• Objective Response Rate (ORR)

  one-year

• Time to Progression (TTP)

  one-year

Other Outcomes (2)

• Biotherapy-related adverse reactions

  one-year

• Blood immunology indicators

  one-year

Study Arms (2)

TAS-102+RAK cell

EXPERIMENTAL

Combined therapy of RAK cells and TAS-102

Biological: RetroNectin active Killer cells; Drug: TAS-102 (trifluridine and tipiracil, Lonsurf®)

TAS-102

ACTIVE COMPARATOR

sole use of TAS-102

Drug: TAS-102 (trifluridine and tipiracil, Lonsurf®)

Interventions

RetroNectin active Killer cells BIOLOGICAL

RetroNectin-Activated Killer (RAK) cells, derived from autologous peripheral blood mononuclear cells (PBMCs), are induced in vitro by RetroNectin along with anti-CD3 monoclonal antibody and Interleukin-2 (IL-2). These cells consist of various cytotoxic effectors, primarily CD8+ T (cytotoxic T, Tc) cells and natural killer T cells, which exhibit minimal cytotoxicity to normal cells but substantial specificity to tumor cells, thereby demonstrating both safety and potent anti-tumor activity.

TAS-102+RAK cell

TAS-102 (trifluridine and tipiracil, Lonsurf®) DRUG

Based on the results of the RECOURSE \[16\] and TERRA \[17\] studies, TAS-102 (Trifluridine/Tipiracil Hydrochloride) will be administered orally at a dose of 35mg/m², twice daily, Days 1-5, with each cycle lasting 3 weeks.

TAS-102; TAS-102+RAK cell

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:

• \. 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).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

The First＆Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

trifluridine tipiracil drug combination; Trifluridine; tipiracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

HongYi Liu, Prof.

CONTACT

86-010-66937523; yunhe_gao301@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: A "double-dummy" method will be used. Based on the randomization results, the investigational drug (RAK cell suspension), TAS-102 (oral drug), and the infusion simulator (normal saline + small amount of fat emulsion) will have their outer packaging marked as either Group A or Group B drugs, making it indistinguishable which is the experimental or control group drug. However, different dosage forms within a group can be distinguished. Medical personnel unaware of the patient's drug group assignment will administer the Group A or Group B drugs to patients according to the corresponding sequence in the randomization table. Unblinding will occur at the end of the study follow-up or when necessary during the treatment process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)