Advanced Lung Cancer Clinical Trial
Official title:
Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Lung Cancer
Verified date | May 2020 |
Source | Fuda Cancer Hospital, Guangzhou |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 27, 2020 |
Est. primary completion date | May 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Institutional Review Board of Guangzhou Fuda Cancer Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Fuda Cancer Hospital, Guangzhou | Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | ORR.The proportion of patients who had a best response rating of complete response and partial response. | 1 year | |
Secondary | Progression-free survival | PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause. | 3 years | |
Secondary | Time tumor progression | TTP.The time of patient from randomization to objective progress of the tumor. | 1 year | |
Secondary | Disease control rate | DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease. | 1 year | |
Secondary | Overall survival | OS.The time of patient from randomization to death caused by any cause | 3 years | |
Secondary | Symptom remission rate | SRR. The proportion of symptoms are alleviated in all evaluative cases. | 1 year |
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