Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Activated T-lymphocyte ("Immuncell-LC") Cell Therapy in Gemcitabine Refractory Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Disease Control Rate
研究概览
简要总结
Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
详细描述
This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer.
If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression and the quality of life should be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug.
- •Patient aged 18 to 75
- •Patient with pathologically-confirmed, advanced pancreatic cancer
- •ECOG scale (ECOG-PS) ≤2 (Appendix
- •Performance status scale/score)
- •Patient with anticipated survival period of more than 3 months
- •Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
- •Patient whose blood test, renal function test and liver function test results meet the following conditions.
排除标准
- •Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.)
- •Confirmed immunodeficient patient
- •Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study
- •Patient who has received systemic anti-angiogenic agent
- •Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
- •Obvious myocardial failure or uncontrolled arterial hypertension
- •Patient who has experienced serious allergy (judged by the investigator)
- •Patient with serious psychological disease (judged by the investigator)
- •Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
- •Patient who has participated in another clinical trial within the last 4 weeks of the start of study
结局指标
主要结局
Disease Control Rate
时间窗: Every 2 months from the baseline, up to 16 weeks
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Disease control rate = CR or PR or SD patients / ITT population \*100
Progressive Disease(PD)
时间窗: Every 2 months from the baseline, up to 16 weeks
Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.
Stable Disease(SD)
时间窗: Every 2 months from the baseline, up to 16 weeks
Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.
次要结局
- Time to Progression(Every 2 months from the baseline, up to 16 weeks)
- Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)(Every one month from the baseline, up to 16 weeks)
- Overall Survival (OS)(Every visit, up to 16 weeks)
- Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)(Every one month from the baseline, up to 16 weeks)