Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
Phase I/IIa, Single-Arm, Open Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní místa
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Jiangsu
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Lianyungang, Jiangsu, Čína, 222000
- The First's People Hospital of Lianyungang
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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:
- 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:
- Pregnant or expecting to pregnant
- Participated in other clinical trials before screening except of observational study.
- Known allergic history of sodium citrate drugs.
- Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
- Known active brain metastases as determined by CT or MRI evaluation.
- The use of immunosuppressive drugs with current or 14 days before enrollment.
- Know the period of systemic and continuous use of immunomodulatory agents (such as interferon, thymosin, traditional Chinese medicine) within 6 months.
- 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).
- Known history of primary immunodeficiency diseases.
- Known history of tuberculosis.
- Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
- Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
- Treatment with any anti-tumors agent within 28days of first administration of study treatment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Apatinib+MASCT
Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma
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Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Ostatní jména:
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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of treatment-related adverse events
Časové okno: up to 2 years
|
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.
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up to 2 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Míra kontroly onemocnění (DCR)
Časové okno: do 2 let
|
Míra kontroly onemocnění je definována jako počet pacientů s nejlepší celkovou odpovědí v podobě kompletní odpovědi (CR), částečné odpovědi (PR) nebo stabilního onemocnění (SD) na základě kritérií RESIST v1.1.
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do 2 let
|
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Progression-Free Survival (PFS)
Časové okno: From enrollment to progression of disease. Estimated about 6 months.
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The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)
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From enrollment to progression of disease. Estimated about 6 months.
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Overall Survival (OS)
Časové okno: From enrollment to death of patients. Estimated about 1 year.
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The length of time from enrollment until the time of death (OS, overall survival)
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From enrollment to death of patients. Estimated about 1 year.
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Objective Response Rate (ORR)
Časové okno: up to 2 years
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clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate)
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up to 2 years
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Novotvary
- Lymfoproliferativní poruchy
- Lymfatická onemocnění
- Imunoproliferativní poruchy
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, T-buňka
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antineoplastická činidla
- Inhibitory proteinkinázy
- Apatinib
Další identifikační čísla studie
- AM-001 (TheraBionic)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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