Recruiting NCT06404528
Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood glucose stress combined with low-dose chemotherapy.
- Who it may be relevant to
- Registry conditions: Solid Tumors, Adult. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Blood glucose stress combined with low-dose chemotherapy
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.
Primary outcome measures
- Relief degree of tumors [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- Progress free survival（PFS） [Time frame: 3 years, year 3]
- Overall survival（OS） [Time frame: 5 years, year 5]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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;
- 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.-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Wuxi People's Hospital — Wuxi
Identifiers
NCT: NCT06404528 · KY23149