The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subjects voluntarily join this study and sign the informed consent form.
- •Age ≥18 years and ≤70 years.
- •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-
- •Expected lifespan ≥1 month.
- •Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
排除标准
- •1. Concurrent other types of malignancy.
- •Severe cardiac, pulmonary, or cerebral system diseases.
- •Expected survival <1 month.
- •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).
研究组 & 干预措施
TAS-102+RAK cell
Combined therapy of RAK cells and TAS-102
干预措施: RetroNectin active Killer cells (Biological)
TAS-102+RAK cell
Combined therapy of RAK cells and TAS-102
干预措施: TAS-102 (trifluridine and tipiracil, Lonsurf®) (Drug)
TAS-102
sole use of TAS-102
干预措施: TAS-102 (trifluridine and tipiracil, Lonsurf®) (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 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.
次要结局
- Overall Survival(one-year)
- Objective Response Rate (ORR)(one-year)
- Time to Progression (TTP)(one-year)
研究者
Lin Chen
Prof.
Chinese PLA General Hospital