本帖最后由 好梦成真 于 2015-2-5 13:58 编辑
北京301医院。如果是肺癌，先将组织切片送检测做个免疫组化HER1。细胞回输费用2.5万元，其它费用与检查方案和治疗方案有关。随后我会将费用比较高的辅助药列出供参考，可与医生商量是否选用，以便降低治疗费用。
联系方式：北京301 解放军总医院 韩卫东主任、丰恺超博士、 杨清明主任 010-55499041
摘自奇迹网豆豆爸： [治疗方案交流] CART临床的相关的信息（经NCI核实的实验组）
临床的主要内容：
treatment of chemotherapy refractory EGFR positive advanced solid tumors(CART-EGFR )
所有医院及联系方式：
Beijing General Hospital of PLA（解放军总医院）
weidong han, Dr Ph: 86-10-13651392893 Email: hanwdrsw@sina.com
Kaichao Feng, Dr Ph: 86-10-13811421950 Email: timothyfkc@126.com
具体入组等相关信息：
Summary
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with EGFR positive advanced solid tumors, such as lung cancer, colorectal cancer and ovary cancer.
Further Study Information
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-EGFR vector (referred to as CART-EGFR cells).
II. Determine duration of in vivo survival of CART-EGFR cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-EGFR TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-tumor response due to CART-EGFR cell infusions.
II. Estimate relative trafficking of CART-EGFR cells in tumor bed.
III. Determine if cellular or humoral host immunity develops against the murine anti-EGFR, and assess correlation with loss of detectable CART-EGFR (loss of engraftment).
IV. Determine the relative subsets of CART-EGFR T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-EGFR-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.
Estimate relative trafficking of CART-EGFR cells in peripheral blood.
Eligibility Criteria
Inclusion Criteria:
1. Chemotherapy refractory EGFR-positive non-small cell lung cancer, colorectal cancer with liver metastasis,and chemotherapy resistant or relapsed ovary cancer.
2. Relapsed patients after anti-EGFR using antibody or kinase inhibitor therapy.
3. Patients must be 18 years of age or older.
4. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
6. Seronegative for HIV antibody.
7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
8. Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
9. Patients must be willing to sign an informed consent.
Exclusion Criteria:
1. Patients with life expectancy less than 12 months will be excluded.
2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
3. Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
5. Pregnant and/or lactating women will be excluded.
6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
7. Patients with any type of primary immunodeficiencies will be excluded from the study.
8. Patients requiring corticosteroids (other than inhaled) will be excluded.
9. Patients with history of T cell tumors will be excluded.
10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
|
显身卡
