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Trial record 38 of 147 for:    visilizumab

Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT03524261
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date September 12, 2019
Estimated Study Start Date  ICMJE April 5, 2020
Estimated Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Objective response rate [ Time Frame: 1 year ]
ORR.The proportion of patients who had a best response rating of complete response and partial response.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03524261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Progression-free survival [ Time Frame: 3 years ]
    PFS.The time of patients from randomization to death caused by the progression of the tumor or any cause.
  • Time tumor progression [ Time Frame: 1 year ]
    TTP.The time of patient from randomization to objective progress of the tumor.
  • Disease control rate [ Time Frame: 1 year ]
    DCR.The proportion of patients who had a best response rating of complete response, partial response,or stable disease.
  • Overall survival [ Time Frame: 3 years ]
    OS.The time of patient from randomization to death caused by any cause
  • Symptom remission rate [ Time Frame: 1 year ]
    SRR. The proportion of symptoms are alleviated in all evaluative cases.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Breast Cancer
Official Title  ICMJE Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Breast Cancer
Brief Summary This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced breast 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 breast cancer.
Detailed Description

Primary breast carcinoma is one of the most common malignancies in China, ranking first in all malignant tumors of women.immunotherapy 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 breast 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a phase II clinical trial of single-center, and it will divide into three groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Advanced Breast Cancer
Intervention  ICMJE
  • Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast 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.
Study Arms  ICMJE
  • Experimental: Cryotherapy
    the maximum tumor length≥2 cm,cool down the lesion,result in degeneration, necrosis or loss of the lesion.
    Intervention: Procedure: cryotherapy
  • Active Comparator: Cryotherapy & Activated CIK and bispecific antibody
    the maximum tumor length≥2cm, use cryotherapy. the maximum tumor length<2 cm,Biological/Vaccine:Activated CIK and bispecific antibody CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
    Interventions:
    • Biological: Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer
    • Procedure: cryotherapy
  • No Intervention: Conventional therapy
    In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 5, 2021
Estimated Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-75 years old
  • The patient is diagnosed as advanced breast 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jibing Chen, Doctor +86-20-38993922 ext 8723 jibingchen398@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03524261
Other Study ID Numbers  ICMJE CD3-MUC1 in breast cancer
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Investigators  ICMJE
Study Chair: Jibing Chen, Doctor Guangzhou Fuda Cancer Hospital
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP