The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
RetroNectin active Killer cells
Biological/VaccineRetroNectin-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 (trifluridine and tipiracil, Lonsurf®)
DrugBased 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: TAS-102+RAK cellExperimental treatment 2 interventions
Group B: TAS-102Active comparator 1 intervention
Trial outcomes
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.
Time frame
one-yearSecondary outcomes
1
Overall Survival
from a defined randomization until death from any cause.
Time frame
one-year2
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.
Time frame
one-year3
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.
Time frame
one-yearOther outcomes
1
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).
Time frame
one-year2
Blood immunology indicators
T-cell count, IL-2/IL-6/IL-11, TGF-β,
Time frame
one-yearSponsors and contacts
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Source ClinicalTrials.gov