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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-102+RAK cell | Experimental | Combined therapy of RAK cells and TAS-102 |
|
| TAS-102 | Active Comparator | sole use of TAS-102 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | from a defined randomization until death from any cause. | one-year |
| Objective Response Rate (ORR) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biotherapy-related adverse reactions | side effects caused by a class of cancer treatments known as Biological Therapies: Dermatitis: Skin rash and itching. Hepatitis: Inflammation of the liver, detected by elevated liver enzymes in blood tests. Pneumonitis: Inflammation of the lungs, causing cough, shortness of breath, and chest pain. This can be life-threatening. Endocrinopathies: Inflammation of hormone glands, leading to conditions like: Thyroiditis (underactive or overactive thyroid). Hypophysitis (inflammation of the pituitary gland). Adrenal Insufficiency (where the body can't manage stress). Less Common but Serious: Can affect almost any organ, including the heart (myocarditis), muscles (myositis), kidneys (nephritis), and nervous system (neuropathy). |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HongYi Liu, Prof. | Contact | 86-010-66937523 | yunhe_gao301@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First＆Fifth Medical Center of Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
The ethics committee which approved this study required the individual participante should be anoymization.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2025 |
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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.
|
| 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. |
|
| one-year |
| Time to Progression (TTP) | 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. | one-year |
| one-year |
| Blood immunology indicators | T-cell count, IL-2/IL-6/IL-11, TGF-β, | one-year |
| Oct 2, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
| D014271 | Trifluridine |
| C000613754 | tipiracil |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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