CervicalNCT05930301
RT201(Tumor Antigen-specific Macrophage Tumor Vaccine)
An observational study of Cervical, run by Peihua Lu at 1 site in China.
Trial summary
This clinical study will include tumor patients in strict accordance with the inclusion and exclusion criteria set in this clinical study, and carry out tumor-specific antigen screening, HLA typing, blood sample collection, cell separation, cell culture and cell reinfusion according to the SOP of Suzhou Ruotai RT201… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Dec 2024
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients (≥18 years old) HPV positive advanced cervical cancer (refer to FIGO standard)
Who may be able to join
- Adult female patients (≥18 years old);
- The patient himself voluntarily signed the "informed consent form";
- HPV positive advanced cervical cancer (refer to FIGO standard);
- Patients with persistent metastasis or recurrence of squamous cell or non-squamous cell need to be confirmed by histology or cytology;
- Patients who have received surgical treatment or other standard first-line treatment or patients who cannot receive surgical treatment/chemotherapy/radiotherapy;
- ECOG≤2
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- Physical condition is good: KPS≥70;
- The estimated survival time is ≥3 months;
- Have not received any treatment that may affect the evaluation of curative effect in the past 3 months;
- The functions of liver, kidney and bone marrow are basically normal: HCT > 25%, white blood cell range 3.5-9.5×109/L, hemoglobin (Hb)≥90g, lymphocyte+monocyte > 20%; Blood Cr≤1.5×UNL (the upper limit of normal) and blood BIL ≤ 1.5× UNL; ALT and AST≤1.5×UNL (for patients with liver metastasis, ALT and ast ≤ 5.0× UNL);
- Women of childbearing age (15-49 years old) must have a pregnancy study within 7 days before starting treatment and the results are negative; Fertile patients must agree to use effective contraceptive measures to ensure that they are not pregnant during the study period and within 3 months after stopping treatment.
Who cannot join
- Patients with central nervous system (CNS) metastasis or active CNS injury (i.e., imaging instability and symptomatic injury) (except patients with a single metastatic focus who are stable after treatment);
- Within 4 weeks before the start of cell infusion, those who have received other anti-tumor treatments, taken corticosteroids (or analogues) or used systemic treatments that affect the immune system;
- Blood pregnancy test positive or lactating female patients;
- Uncontrolled accompanying diseases and active infectious diseases;
- Patients who need anticoagulant therapy (warfarin or heparin);
- The patient was allergic to naproxen, ibuprofen, trimetazidine/sulfamethoxazole and ampicillin.
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- Have a history of bone marrow transplantation or organ transplantation.
- Patients who have previously used gene therapy drugs;
- Patients with the following previous diseases or accompanying diseases:a) Patients who have been diagnosed as serious autoimmune diseases need systemic immunosuppressants (steroids) for a long time (more than 2 months) or immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and autoimmune vasculitis (for example, Wegener's granulomatosis;b) Patients previously diagnosed with motor neuron disease caused by autoimmune disease; c) Patients with toxic epidermal necrolysis (TEN) in the past; d) Patients suffering from any mental illness, including dementia and mental state changes, which may affect informed consent and the understanding and performance of relevant questionnaires;e) It is determined that patients with serious uncontrollable diseases may be affected by this study; f) Patients with active malignant tumors such as basal or squamous skin cancer, superficial bladder cancer and breast cancer in situ in the past 5 years who have been completely cured and do not need follow-up treatment are not included;
- Patients who have used immunotherapy for cancer in the past 6 months include: CIK, DC, DC-CIK, LAK and other lymphocyte-based immunotherapy patients;
- Active/chronic human immunodeficiency virus (HIV), syphilis serological positive, active hepatitis B (hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > 500IU/ml or the lower detection limit of the research center [only when the lower detection limit of the research center is higher than 500 iu/ml]), or hepatitis C virus antibody positive;
- Have a clear history of drug allergy or an allergic constitution; Patients participating in other clinical trials at the same time Other circumstances in which the researcher thinks that the patient should not participate in this experimental study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214043
Peihua Lu, MD, +86 13621500031, 13625653@qq.com
About this study
Official title: Clinical Research on the Safety and Effectiveness of RT201(Tumor Antigen-specific Macrophage Tumor Vaccine) in the Treatment of Advanced Cervical Cancer
This clinical study will include tumor patients in strict accordance with the inclusion and exclusion criteria set in this clinical study, and carry out tumor-specific antigen screening, HLA typing, blood sample collection, cell separation, cell culture and cell reinfusion according to the SOP of Suzhou Ruotai RT201 Cell Therapy. According to the efficacy evaluation criteria set in this clinical study, the included patients will be evaluated and followed up for a long time, and the original data will be saved to provide real and effective clinical data for the safety and efficacy of RT201 tumor single-target individualized clinical treatment.
- Conditions
- Cervical
- Keywords
- Cervical cancer, advanced malignant tumor, Listeria monocytogenes
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single | Mode of administration：IV Administration dosage：10^7/100ml Dosing frequency：Every three weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective remission rate assessed by the independent review committee according to RECIST1.1.
Main efficacy indicators
Measured: The time from the first administration to the first observation of disease recurrence or death of the patient was evaluated for up to 36 weeks.
Secondary outcomes (2)
Disease control rate (DCR)
Secondary efficacy indicators
Measured: The percentage of subjects who reached CR, PR and SD after treatment was analyzed.No more than 36 weeks.
Progression-free survival (PFS)
Secondary efficacy indicators
Measured: The time interval between the patient's first treatment and the first record of disease progression or death.No more than 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Oct 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peihua Lu
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Royaltechmed Co.,Ltd.
- Responsible party
- Sponsor-investigator, Peihua Lu, Wuxi People's Hospital
- Investigators
- Peihua Lu, doctor, Study director, Self
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930301
- Sponsor's protocol ID
- WuxiPH
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Safety and Effectiveness of RT201(Tumor Antigen-specific Macrophage Tumor Vaccine) in the Treatment of Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05930301
- Acronym / sponsor ID
- WuxiPH
- Conditions
- Cervical
- Keywords
- Cervical cancer, advanced malignant tumor, Listeria monocytogenes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peihua LuUniversity, hospital or other
- Collaborators
- Suzhou Royaltechmed Co.,Ltd.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Jul 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 clinical study will include tumor patients in strict accordance with the inclusion and exclusion criteria set in this clinical study, and carry out tumor-specific antigen screening, HLA typing, blood sample collection, cell separation, cell culture and cell reinfusion according to the SOP of Suzhou Ruotai RT201 Cell Therapy. According to the efficacy evaluation criteria set in this clinical study, the included patients will be evaluated and followed up for a long time, and the original data will be saved to provide real and effective clinical data for the safety and efficacy of RT201 tumor single-target individualized clinical treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single | – | –Mode of administration：IV Administration dosage：10^7/100ml Dosing frequency：Every three weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients (≥18 years old) HPV positive advanced cervical cancer (refer to FIGO standard)
Key inclusion criteria (11 listed)
- Adult female patients (≥18 years old);
- The patient himself voluntarily signed the "informed consent form";
- HPV positive advanced cervical cancer (refer to FIGO standard);
- Patients with persistent metastasis or recurrence of squamous cell or non-squamous cell need to be confirmed by histology or cytology;
- Patients who have received surgical treatment or other standard first-line treatment or patients who cannot receive surgical treatment/chemotherapy/radiotherapy;
Key exclusion criteria (12 listed)
- Patients with central nervous system (CNS) metastasis or active CNS injury (i.e., imaging instability and symptomatic injury) (except patients with a single metastatic focus who are stable after treatment);
- Within 4 weeks before the start of cell infusion, those who have received other anti-tumor treatments, taken corticosteroids (or analogues) or used systemic treatments that affect the immune system;
- Blood pregnancy test positive or lactating female patients;
- Uncontrolled accompanying diseases and active infectious diseases;
- Patients who need anticoagulant therapy (warfarin or heparin);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The objective remission rate assessed by the independent review committee according to RECIST1.1.
Time frame: The time from the first administration to the first observation of disease recurrence or death of the patient was evaluated for up to 36 weeks.
Main efficacy indicators
2 secondary outcomes
Disease control rate (DCR)
Time frame: The percentage of subjects who reached CR, PR and SD after treatment was analyzed.No more than 36 weeks.
Progression-free survival (PFS)
Time frame: The time interval between the patient's first treatment and the first record of disease progression or death.No more than 36 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Peihua Lu, doctor study director
Self
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical, run by Peihua Lu 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 11 inclusion and 12 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 5 Jul 2023. 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.
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?
The objective remission rate assessed by the independent review committee according to RECIST1.1. (time frame: The time from the first administration to the first observation of disease recurrence or death of the patient was evaluated for up to 36 weeks.). 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 5 Jul 2023.