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
1 other identifier
interventional
60
1 country
1
Brief Summary
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 11, 2016
July 1, 2016
2 years
July 20, 2016
August 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Progression-Free Survival (PFS)
From enrollment to progression of disease. Estimated about 6 months.
Overall Survival (OS)
From enrollment to death of patients. Estimated about 1 year.
Objective Response Rate (ORR)
up to 2 years
Disease Control Rate (DCR)
up to 2 years
Study Arms (1)
Apatinib+MASCT
EXPERIMENTALApatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma
Interventions
Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
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
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First's People Hospital of Lianyungang
Lianyungang, Jiangsu, 222000, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 26, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
August 11, 2016
Record last verified: 2016-07