Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Pancreatic Cancer
NCT ID: NCT03509298
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-04-12
2020-07-12
Brief Summary
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Detailed Description
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The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
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
Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic Cancer
CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
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).
No interventions assigned to this group
Interventions
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Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic Cancer
CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
cryotherapy
the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
Eligibility Criteria
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Inclusion Criteria
* The patient is diagnosed as advanced pancreatic 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
INDUSTRY
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Jibing Chen, Doctor
Role: STUDY_CHAIR
Guangzhou Fuda Cancer Hospital
Locations
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Institutional Review Board of Guangzhou Fuda Cancer Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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CD3-MUC1 in pancreatic cancer
Identifier Type: -
Identifier Source: org_study_id
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