Solid Tumors, AdultNCT06404528
Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours
A study testing Blood glucose stress combined with low-dose chemotherapy in people with Solid Tumors, Adult, run by Wuxi People's Hospital at 1 site in China.
Trial summary
By controlling the patient's blood sugar, small doses of chemotherapy are used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, and produce very strong anticancer effects without the cytotoxic effects of chemotherapy. 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?
- Blood glucose stress combined with low-dose chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214043
Peihua Lu, MD, 13621500031, 13625653@qq.com
About this study
Official title: A Clinical Study on the Efficacy and Mechanism of Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours
By controlling the patient's blood sugar, small doses of chemotherapy are used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, and produce very strong anticancer effects without the cytotoxic effects of chemotherapy.
- Conditions
- Solid Tumors, Adult
- Being tested
- Blood glucose stress combined with low-dose chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose stress combined with low-dose chemotherapyOther
By controlling the patient's blood sugar, low-dose chemotherapy is used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, produce very strong anticancer effects, and have no cytotoxic reactions to chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Blood glucose stress combined with low-dose chemotherapy | Experimental | By controlling the patient's blood sugar, low-dose chemotherapy is used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, produce very strong anticancer effects, and have no cytotoxic reactions to chemotherapy. Receives: Other: Blood glucose stress combined with low-dose chemotherapy |
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: through study completion, an average of 1 year
Secondary outcomes (2)
Progress free survival（PFS）
The duration from the beginning of treatment to cancer recurrence or progression
Measured: 3 years, year 3
Overall survival（OS）
The duration from the beginning of treatment to patient death
Measured: 5 years, year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start4 Sep 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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
- 300 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
- NCT06404528
- Sponsor's protocol ID
- KY23149
- Status last verified
- May 2024
- First submitted
- 23 Oct 2023
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Mechanism of Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06404528
- Acronym / sponsor ID
- KY23149
- Conditions
- Solid Tumors, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 May 2024 (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.
By controlling the patient's blood sugar, small doses of chemotherapy are used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, and produce very strong anticancer effects without the cytotoxic effects of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood glucose stress combined with low-dose chemotherapy | Experimental | Other: Blood glucose stress combined with low-dose chemotherapyBy controlling the patient's blood sugar, low-dose chemotherapy is used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, produce very strong anticancer effects, and have no cytotoxic reactions to chemotherapy. |
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 |
|---|---|---|
| Blood glucose stress combined with low-dose chemotherapyBy controlling the patient's blood sugar, low-dose chemotherapy is used in a hypoglycemic state. Some necrotic tumor cells produced by chemotherapy can maintain their immunogenicity, further activate innate immunity, produce very strong anticancer effects, and have no cytotoxic reactions to chemotherapy. | Other | Blood glucose stress combined with low-dose chemotherapy |
Primary outcome
Relief degree of tumors
Time frame: through study completion, an average of 1 year
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
2 secondary outcomes
Progress free survival（PFS）
Time frame: 3 years, year 3
Overall survival（OS）
Time frame: 5 years, year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose stress combined with low-dose chemotherapy in people with Solid Tumors, Adult, run by Wuxi People's Hospital 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 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: looking for participants now, as of the sponsor's last update on 8 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peihua Lu (0510-85350835, 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: through study completion, an average of 1 year). 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 8 May 2024.