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| Name | Class |
|---|---|
| Hengrui Yuanzheng Bio-Technology Co., Ltd. | INDUSTRY |
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The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.
Angiogenesis is a hallmark of cancer, together with vascular endothelial growth factor (VEGF) as one of the most important angiogenic drivers. Inhibitors targeting the VEGF/VEGFR-pathway have shown beneficial effects in many cancer patients, but they are transient and followed by fast regrowth. Similarly, the effectiveness of tumor immunotherapies has been limited by tumor-mediated escape mechanisms and immune suppression. By combining the two strategies, antiangiogenic immunotherapy offers the possibility to more vigorously inhibit tumor angiogenesis and promote an enduring immune-stimulatory milieu that leads to prolonged survival benefits in cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib+MASCT | Experimental | Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events | The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The length of time from enrollment until the time of progression of disease (PFS, progression-free survival) | From enrollment to progression of disease. Estimated about 6 months. |
| Overall Survival (OS) |
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Inclusion Criteria:
Patients with histologically-confirmed, advanced (unresectable) solid tumors who have progressed on standard therapy.
With written informed consent signed voluntarily by patients themselves.
The time of between Patients enrollment and the end of other anti-tumors therapies≤1 month
Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
At least one measurable lesion as defined by RECIST criteria 1.1 for solid tumors.
Life expectancy ≥6 months.
With normal cardiopulmonary function.
Patients have adequate organ function as defined by the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Jiang, Doctor | Contact | +86018961326201 | jxdysy1970@163.com | |
| Kaiyuan Hui, Doctor | Contact | +86018961327098 | kyhui1987@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First's People Hospital of Lianyungang | Lianyungang | Jiangsu | 222000 | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| MASCT | Biological | 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 |
|
|
The length of time from enrollment until the time of death (OS, overall survival)
| From enrollment to death of patients. Estimated about 1 year. |
| Objective Response Rate (ORR) | clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate) | up to 2 years |
| Disease Control Rate (DCR) | Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria. | up to 2 years |