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Study of Apatinib and MASCT in Patients With Advanced Solid Tumors

Primary Purpose

Advanced Solid Tumors, Excluding T Cell Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Apatinib

MASCT

About this trial

This is an interventional treatment trial for Advanced Solid Tumors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First's People Hospital of Lianyungang

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib+MASCT

Arm Description

Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-Free Survival (PFS)

The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)

Overall Survival (OS)

The length of time from enrollment until the time of death (OS, overall survival)

Objective Response Rate (ORR)

clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate)

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.

Full Information

NCT ID

NCT02844881

First Posted

July 20, 2016

Last Updated

August 9, 2016

Sponsor

The First People's Hospital of Lianyungang

Collaborators

Hengrui Yuanzheng Bio-Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02844881

Brief Title

Study of Apatinib and MASCT in Patients With Advanced Solid Tumors

Official Title

Phase I/IIa, Single-Arm, Open Study of Apatinib and MASCT in Patients With Advanced Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First People's Hospital of Lianyungang

Collaborators

Hengrui Yuanzheng Bio-Technology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Solid Tumors, Excluding T Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib+MASCT

Arm Type

Experimental

Arm Description

Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

YN968D1

Intervention Description

Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Intervention Type

Biological

Intervention Name(s)

MASCT

Other Intervention Name(s)

Multiple Antigens Specific Cellular Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of treatment-related adverse events

Description

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.

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)

Time Frame

From enrollment to progression of disease. Estimated about 6 months.

Title

Overall Survival (OS)

Description

The length of time from enrollment until the time of death (OS, overall survival)

Time Frame

From enrollment to death of patients. Estimated about 1 year.

Title

Objective Response Rate (ORR)

Description

clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate)

Time Frame

up to 2 years

Title

Disease Control Rate (DCR)

Description

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.

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaodong Jiang, Doctor

Phone

+86018961326201

jxdysy1970@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kaiyuan Hui, Doctor

Phone

+86018961327098

kyhui1987@163.com

Facility Information:

Facility Name

The First's People Hospital of Lianyungang

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaodong Jiang, Doctor

Phone

+86018961326201

jxdysy1970@163.com

First Name & Middle Initial & Last Name & Degree

Kaiyuan Hui, Doctor

Phone

+86018961327098

kyhui1987@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Study of Apatinib and MASCT in Patients With Advanced Solid Tumors

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