Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
NCT ID: NCT02844881
Last Updated: 2016-08-11
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
60 participants
INTERVENTIONAL
2016-07-31
2018-07-31
Brief Summary
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Detailed Description
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Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). Apatinib has been demonstrated as monotherapy prolongs OS in patients with gastric or gastroesophageal junction adenocarcinoma after two or more lines of chemotherapy with moderate, reversible, and easily managed adverse events.
Multiple antigens specific cellular therapy (MASCT) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with 17 antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients.
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Apatinib+MASCT
Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma
Apatinib
Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
MASCT
Dendritic cells(DC) loaded with 17 antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Interventions
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Apatinib
Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
MASCT
Dendritic cells(DC) loaded with 17 antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. With written informed consent signed voluntarily by patients themselves.
3. The time of between Patients enrollment and the end of other anti-tumors therapies≤1 month
4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
5. At least one measurable lesion as defined by RECIST criteria 1.1 for solid tumors.
6. Life expectancy ≥6 months.
7. With normal cardiopulmonary function.
8. Patients have adequate organ function as defined by the following criteria:
* Hemoglobin (HGB) ≥85g/L
* Absolute neutrophil count (ANC) ≥1.0×109/L
* White blood cell (WBC) ≥3.0×109/L
* Platelet count ≥50×109/L
* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis
* Alkaline phosphatase (ALP)≤2.5 UNL
* Total bilirubin (TBil) of ≤1.5 UNL
* Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL
* Albumin (ALB) ≥30g/L
Exclusion Criteria
2. Participated in other clinical trials before screening except of observational study.
3. Known allergic history of sodium citrate drugs.
4. Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
5. Known active brain metastases as determined by CT or MRI evaluation.
6. The use of immunosuppressive drugs with current or 14 days before enrollment.
7. Know the period of systemic and continuous use of immunomodulatory agents (such as interferon, thymosin, traditional Chinese medicine) within 6 months.
8. Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation).
9. Known history of primary immunodeficiency diseases.
10. Known history of tuberculosis.
11. Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
12. Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
13. Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
14. Treatment with any anti-tumors agent within 28days of first administration of study treatment.
18 Years
80 Years
ALL
No
Sponsors
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Hengrui Yuanzheng Bio-Technology Co., Ltd.
INDUSTRY
The First People's Hospital of Lianyungang
OTHER
Responsible Party
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Locations
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The First's People Hospital of Lianyungang
Lianyungang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AM-001
Identifier Type: -
Identifier Source: org_study_id
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