Using low-dose chemotherapy with controlled blood sugar to treat advanced solid tumors

A Clinical Study on the Efficacy and Mechanism of Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours

This study is testing if giving low-dose chemotherapy while keeping blood sugar levels low can help patients with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wuxi People's Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT06404528 on ClinicalTrials.gov

What this trial studies

This study investigates the use of low-dose chemotherapy administered under hypoglycemic conditions to treat patients with relapsed refractory advanced solid tumors. By managing blood sugar levels, the approach aims to enhance the immune response against tumor cells while minimizing the cytotoxic effects typically associated with chemotherapy. Patients will receive treatment at Wuxi People's Hospital, where their progress will be monitored based on measurable tumor lesions. The study focuses on patients who have not responded to standard therapies and have specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors that have progressed despite standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and less toxic treatment option for patients with advanced solid tumors.

How similar studies have performed: While this specific approach is novel, similar studies exploring low-dose chemotherapy and immunogenic responses have shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged 18-75 years;
2. 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;
3. 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);
4. ECOG score of 0-2, lifespan \> 12 weeks;
5. 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;
6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up

Exclusion Criteria:

1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
6. 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;
7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
10. 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;
11. Subjects in other conditions that are considered unsuitable for this study by the investigator.-

Where this trial is running

Wuxi, Jiangsu

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

Study contacts

• Study coordinator: Peihua Lu

Conditions: Solid Tumors, Adult