Study of DC-CIK Combined With Chemotherapy for Advanced Solid Tumor
DC-CIK
Study of Dendritic Cell-activated Cytokine-induced Killer Cell Combined With Chemotherapy for Advanced Solid Tumor
1 other identifier
interventional
60
1 country
1
Brief Summary
Combinations of Dendritic cell-activated cytokine-induced killer cell (DC-CIK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2019
CompletedStudy Start
First participant enrolled
December 31, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 28, 2023
March 1, 2023
4 years
December 30, 2019
March 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Disease Control Rates (DCR)
Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (Response evaluation criteria in solid tumors, RECIST).
1 year
Study Arms (2)
Combination of DC-CIK with chemotherapy group
EXPERIMENTALPatients will receive DC-CIK treatments combined with Chemotherapy .
Chemotherapy group
ACTIVE COMPARATORPatients will only receive Chemotherapy.
Interventions
Patients will receive 4 cycles of DC-CIK treatments combined with Chemotherapy within 8 months.
Eligibility Criteria
You may qualify if:
- Patients with treatment-refractory advanced solid cancer can not accept operation;
- Age 10 to 90 years;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- Estimate survival \> 3 months;
- Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
- Without any other malignant disease;
- With more than one scalable lesions;
- Patients Voluntary attempt, and informed consent;
- Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
You may not qualify if:
- Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
- Patients who were pregnant or lactating;
- ECOG perform status ≥ 2;4.
- Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peiwen Lian, PhD
Yantai Yuhuangding Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 2, 2020
Study Start
December 31, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
March 28, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share