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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03501056
Other study ID # CD3-MUC1 in lung cancer
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date March 27, 2018
Est. completion date July 27, 2020

Study information

Verified date May 2020
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Lung cancer
CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
Procedure:
Cryotherapy
the maximum tumor length=2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.

Locations

Country Name City State
China Institutional Review Board of Guangzhou Fuda Cancer Hospital Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Fuda Cancer Hospital, Guangzhou Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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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