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

Last updated: May 6, 2024
Sponsor: Wuxi People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Hormone Deficiencies

Treatment

Blood glucose stress combined with low-dose chemotherapy

Clinical Study ID

NCT06404528
KY23149
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged 18-75 years;
  2. ASubjects must have histologically- or cytologically-confirmed diagnosis of advancedsolid tumor(s) and have progressed on or is not eligible for available standardtherapy;
  3. Subjects have at least one measurable lesion according to Response Evaluation Criteriain Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, ornodal 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 beforetreatment. Female patients of childbearing age, and male patients with partners ofchildbearing age must agree to use at least one medically recognized contraceptivemethod during study treatment and within at least 6 months after the last dose ofinvestigational drug;
  6. Voluntarily participated in this study, signed the informed consent form, had goodcompliance, and cooperated with the follow-up

Exclusion

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'tbe guaranteed to complete a full treatment cycle;
  3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiringfour-level isolation treatment.
  4. HIV, HBV and HCV positive;
  5. Patients with diseases of the central nervous system or autoimmune central nervoussystem lesions, Including stroke, epilepsy, dementia;
  6. Patients have myocardial infection, cardiac angiography or stents, active angina orother obvious clinical symptoms, or have cardiopathic asthma or cardiovascularlymphocytic 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 otherimmunosuppressive agents within 2weeks prior to investigational drug administration;
  9. Patients were infected with covid-19 within 2weeks prior to investigational drugadministration;
  10. Subjects having any serious uncontrolled disease or in other conditions that wouldpreclude them from receiving study treatment and are considered unsuitable for thisstudy in the opinion of the investigator;
  11. Subjects in other conditions that are considered unsuitable for this study by theinvestigator.-

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Blood glucose stress combined with low-dose chemotherapy
Phase:
Study Start date:
September 04, 2023
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214043
    China

    Active - Recruiting

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