Solid Tumors, AdultNCT05747339
A Clinical Study on the Efficacy and Mechanism of Tumor Treatment Vaccine (TTV) for Recurrent and Refractory Advanced Solid Tumors
A study testing tumor treatment vaccine injection in people with Solid Tumors, Adult, run by Wuxi People's Hospital.
Trial summary
This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- tumor treatment vaccine injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2023to 31 Dec 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-75 years;
- ASubjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
- Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- ECOG score of 0-2, lifespan > 12 weeks;
- Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
- Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
- White blood cell count ≥ 50×10^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
- Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
- HIV, HBV and HCV positive;
- Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
- Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
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- Patients are on anticoagulation or have severe coagulopathy (APTT>70);
- Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
- Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
- Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
- Subjects in other conditions that are considered unsuitable for this study by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Tumor Treatment Vaccine in Patients With Advanced Solid Tumors
This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid tumors.
Read the detailed description
The study aims to explore the safety and effectiveness of Neo-BCV in the treatment of advanced solid tumors.The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
- Conditions
- Solid Tumors, Adult
- Being tested
- tumor treatment vaccine injection
- Keywords
- Tumor immunotherapy, Tumor vaccine, Advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor treatment vaccine injectionBiological
Patients will receive tumor treatment vaccine(TTV), which would be given deep subcutaneously in the arm or near the tumor.The initial dose is 1ml / week, if the reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml / week.The interval between injections can be shortened or extended depending on the patient's condition and response.The duration of treatment should be extended as long as possible, at least 6-12 months.
| Study group | Role | What they receive |
|---|---|---|
| Tumor treatment vaccine for patients with advanced solid tumors | Experimental | Tumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor.The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Receives: Biological: tumor treatment vaccine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
Measured: The last injection
Secondary outcomes (2)
Progress free survival（PFS）
The duration from the beginning of treatment to cancer recurrence or progression
Measured: 1 year
Overall survival（OS）
The duration from the beginning of treatment to patient death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start7 Jun 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747339
- Sponsor's protocol ID
- KY23009
- Status last verified
- Jun 2023
- First submitted
- 16 Feb 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tumor Treatment Vaccine in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05747339
- Acronym / sponsor ID
- KY23009
- Conditions
- Solid Tumors, Adult
- Keywords
- Tumor immunotherapy, Tumor vaccine, Advanced solid tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Study start
- 7 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2023 (actual)
- 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.
This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid tumors.
Detailed description
The study aims to explore the safety and effectiveness of Neo-BCV in the treatment of advanced solid tumors.The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor treatment vaccine for patients with advanced solid tumors | Experimental | Biological: tumor treatment vaccine injectionTumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor.The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18-75 years;
- ASubjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
- Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- ECOG score of 0-2, lifespan > 12 weeks;
- Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
Key exclusion criteria (11 listed)
- The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
- White blood cell count ≥ 50×10^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
- Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
- HIV, HBV and HCV positive;
- Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
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 |
|---|---|---|
| tumor treatment vaccine injectionPatients will receive tumor treatment vaccine(TTV), which would be given deep subcutaneously in the arm or near the tumor.The initial dose is 1ml / week, if the reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml / week.The interval between injections can be shortened or extended depending on the patient's condition and response.The duration of treatment should be extended as long as possible, at least 6-12 months. | Biological | Tumor treatment vaccine for patients with advanced solid tumors |
Primary outcome
Relief degree of tumors
Time frame: The last injection
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
2 secondary outcomes
Progress free survival（PFS）
Time frame: 1 year
Overall survival（OS）
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing tumor treatment vaccine injection in people with Solid Tumors, Adult, run by Wuxi People's Hospital.
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 6 inclusion and 11 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Peihua Lu, Doctor (13621500031, 13625653@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief degree of tumors (time frame: The last injection). 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 13 Jun 2023.