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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Jiangsu
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Lianyungang、Jiangsu、中国、222000
- The First's People Hospital of Lianyungang
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of treatment-related adverse events
時間枠：up to 2 years
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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疾病制御率 (DCR)
時間枠：2年まで
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病勢制御率は、RESIST v1.1 基準に基づいて、完全奏効 (CR)、部分奏効 (PR)、または病勢安定 (SD) の最良の全体奏効を示す患者の数として定義されます。
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2年まで
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Progression-Free Survival (PFS)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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