Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced lung cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1 bispecific antibody for lung cancer.
详细描述
Primary pulmonary carcinoma is one of the most common malignancies in China, ranking first in all malignant tumors and mortality.Immunetherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single- center, The investigators plan to recruit for 90 patients with advanced lung cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive conventional therapy，and the rest one will receive mixed liquor of activated CIK and anti-CD3-MUC1 bispecific antibody together with cryotherapy.
The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
With the method of minimum randomized dynamic random by the interactive network response system (IWRS),Participants were assigned to three groups,receive cryotherapy,conventional therapy, and activated CIK armed with anti-CD3-MUC1 bispecific antibody together with cryotherapy .every participant has a unique identification number and emergency letter which have the information of group.
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
- •18-75 years old
- •The patient is diagnosed as advanced lung cancer,MUC1 is positive
- •There is at least one tumor should be measured,and length≥10mm of focus not at lymph node or length≥10mm of focus at lymph node
- •The patient can't tolerate system(systemic chemotherapy/molecular targeted therapy) or local therapies
- •If the patient received adjuvant chemotherapy after local treatment,the time should be more than 4 weeks after the end of chemotherapy, and disease progression or metastasis patients can also assigned into the group
- •The time of surgical treatment≥ 3 months ;At the end of the intervention,radiotherapy and the end of the ablation time is more than 4 weeks
- •The expected survival time ≥12 weeks
- •The patient did not took any antitumor drugs within 4 weeks(any antitumor drugs, Chinese patent medicine including Delisheng injection,Kanglaite injection, Aidi injection
- •No serious disease are conflicts with the solution(such as autoimmune disease,immunodeficiency,organ transplantation)
- •Sign the informed consent
排除标准
- •medium or above ascites
- •Patient of second primary tumor or multiple primary cancer
- •Patients of T cell lymphoma、myeloma,and patients are using immunosuppressant
- •Systemic autoimmune diseases, allergic constitution or immunocompromised patients
- •Patients of chronic diseases need immune stimulant or hormone therapy
- •Patients of active bleeding or coagulant function abnormality（PT>16s、APTT>43s、TT>21s、INR≥2）,and patients of bleeding tendency or are receiving thrombolysis and anticoagulation and antiplatelet therapy
- •Women who is pregnant or during breast feeding or plan to pregnant in 2 years,and not willing to contraception during the test
- •Patients with brain、dura mater metastases or history of psychogenic
- •Gastrointestinal bleeding in the past six months or have clear gastrointestinal bleeding tendency,such as: patients of local active ulcerative lesions, defecate occult blood + + above shall not enter into group; defecate occult blood + depend on gastroscopy
- •Patients with severe stomach/esophageal varices and need for intervention treatment
- •Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within 4 weeks before the first treatment
- •Positive for HIV antibody
- •Patients who are allergic to computed tomography (CT) and magnetic resonance imaging (MRI) contrast agents at the same time, can't imaging assay
- •Patients accepted any experimental drugs or pilot medical apparatus and instruments in the past 4 weeks of first treatment
- •Other reasons the researchers think not suitable
结局指标
主要结局
Objective response rate
时间窗: 1 year
ORR.The proportion of patients who had a best response rating of complete response and partial response.
次要结局
- Progression-free survival(3 years)
- Symptom remission rate(1 year)
- Time tumor progression(1 year)
- Disease control rate(1 year)
- Overall survival(3 years)