Advanced Solid TumorsPhase 1/2NCT02844881
Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
A Phase 1/2 study testing Apatinib and MASCT in people with Advanced Solid Tumors and Excluding T Cell Lymphoma, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumors, Excluding T Cell Lymphoma
- What is being tested?
- Apatinib and MASCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First's People Hospital of Lianyungang
Lianyungang, Jiangsu, 222000
Xiaodong Jiang, Doctor, +86018961326201, jxdysy1970@163.com
Kaiyuan Hui, Doctor, +86018961327098, kyhui1987@163.com
About this study
Official title: Phase I/IIa, Single-Arm, Open Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.
Read the 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.
- Conditions
- Advanced Solid Tumors, Excluding T Cell Lymphoma
- Being tested
- Apatinib, MASCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called YN968D1
Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
MASCTBiological
Also called Multiple Antigens Specific Cellular Therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Apatinib+MASCT | Experimental | Apatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma Receives: Drug: Apatinib; Biological: MASCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (4)
Progression-Free Survival (PFS)
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)
Measured: From enrollment to progression of disease. Estimated about 6 months.
Overall Survival (OS)
The length of time from enrollment until the time of death (OS, overall survival)
Measured: 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)
Measured: 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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Collaborators
- Hengrui Yuanzheng Bio-Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844881
- Sponsor's protocol ID
- AM-001
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa, Single-Arm, Open Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02844881
- Acronym / sponsor ID
- AM-001
- Conditions
- Advanced Solid Tumors, Excluding T Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Collaborators
- Hengrui Yuanzheng Bio-Technology Co., Ltd.
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib+MASCT | Experimental | Drug: Apatinib, Biological: MASCTApatinib+Multiple Antigens Specific Cellular Therapy(MASCT) in patients with advanced solid tumors,excluding T cell lymphoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibAlso: YN968D1Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | Drug | Apatinib+MASCT |
| MASCTAlso: Multiple Antigens Specific Cellular TherapyDendritic 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 | Biological | Apatinib+MASCT |
Primary outcome
Incidence of treatment-related adverse events
Time frame: 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.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment to progression of disease. Estimated about 6 months.
Overall Survival (OS)
Time frame: From enrollment to death of patients. Estimated about 1 year.
Objective Response Rate (ORR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: Undecided
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apatinib and MASCT in people with Advanced Solid Tumors and Excluding T Cell Lymphoma, run by The First People's Hospital of Lianyungang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Jiang, Doctor (+86018961326201, jxdysy1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.