Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours

Recruiting now · Not applicable

Conditions studied: Solid Tumors, Adult

In brief

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.

Key facts

Study ID

NCT06404528

Run by

Wuxi People's Hospital

People needed

300

Starts

2023-09-04

Expected to finish

2028-12-31

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.-

Where it is running

• Wuxi People's Hospital — Wuxi, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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