Study of DC-CTL Combined With CIK for Advanced Solid Tumor
NCT ID: NCT03047525
Last Updated: 2017-02-09
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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UNKNOWN
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2017-02-20
2020-12-01
Brief Summary
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Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.
Study treatment:
Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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control group
patients will just regularly chemotherapy
No interventions assigned to this group
DC-CIK and CIK Immunotherapy
patients will receive chemotherapy with 4 cycles of DC-CIK treatment and 4 cycles of CIK treatment .
Cytokine-induced Killer Cells
Concurrent of chemotherapy plus 4 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment and 4 cycles of Cytokine-induced Killer Cells(CIK) treatment
Interventions
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Cytokine-induced Killer Cells
Concurrent of chemotherapy plus 4 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment and 4 cycles of Cytokine-induced Killer Cells(CIK) treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival \> 3 months;
3. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count(PLT)≥ 80×109/L; Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
4. Without any other malignant disease;
5. With more than one scalable lesions
6. Patients Voluntary attempt, and informed consent.
7. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating;
3. ECOG perform status ≥ 2;
4. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..
18 Years
75 Years
ALL
No
Sponsors
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Xiaoyi Huang
OTHER
Responsible Party
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Xiaoyi Huang
Director of The Heilongjiang Cancer Biotherapy Center
Locations
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Harbin Medical University Cancer Hospital
Harbin, , China
Countries
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Central Contacts
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Xiaoyi Huang
Role: CONTACT
Qi Li
Role: CONTACT
Facility Contacts
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Yi X Huang
Role: primary
Qi Li
Role: backup
Other Identifiers
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HMU-2016-002
Identifier Type: -
Identifier Source: org_study_id
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