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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-15006946 |
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Date of registration:
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2015-08-20 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical research on the safety and efficacy of iAPDA-DC/CTL treatment on malignant tumor of digestive system (mainly in biliary system and pancreas)
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Scientific title:
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clinical research on the safety and efficacy of new cellular immunotherapy on advanced panreatic cancer |
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Date of first enrolment:
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2015-08-18 |
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Target sample size:
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control group :62;treatment group :125; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=11675 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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I+II (Phase I+Phase II)
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Countries of recruitment
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China
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Contacts
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Name:
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Jun Gao
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Address:
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168 Changhai Road, Yangpu district, Shanghai
200433
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Telephone:
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+86 13816012151 |
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Email:
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13816012151@163.com |
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Affiliation:
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Changhai hospital |
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Name:
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Zhaoshen Li
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Address:
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168 Changhai Road, Yangpu district, Shanghai
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Telephone:
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+86 021-25070552 |
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Email:
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zhaoshenlismmu@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Advanced Pancreatic cancer patients with Histological pathology confirmation;
2. Both gender, aged 18-70 year-old;
3. Bone marrow functioned well;
4. Renal function normal;
5. Liver function normal;
6. patients are voluntary, and willing to sign informed consent;
7. expected lifetime was at least more than 3 months.
Exclusion criteria: 1. With acute inflammation;
2. Accompanied with primary malignant tumor other than pancreas;
3. with autoimmune disease;
4. using corticosteroid or other suppress immune hormone treatment;
5. had transplant operation of vital organs;
6. active hepatitis;
7. HIV positive;
8. dysfunction in blood coagulation;
9. serious diseases in circulatory and respiratory systems;
10. pregnancy or breast-feeding women.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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pancreatic ductal adenocarcinoma
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Intervention(s)
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control group :Gemcitabine ;treatment group :iAPA-DC/CTL+Gemcitabine ;
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Primary Outcome(s)
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6 months survival rate;
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Secondary Outcome(s)
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Overall Survival;Progression-Free Survival;Objective Response Rate;Quality of life;
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Source(s) of Monetary Support
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Changhai Hospital, Shanghai; ImmunoGene Biotechnology Co., Ltd, Beijing, Guze hospital investment& management Co., Ltd, Shanghai
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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