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NCT Number: NCT06404528

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

Location status: Recruiting

Location contact

Peihua Lu, MD

CONTACT

[email protected]

13621500031

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

Blood glucose stress combined with low-dose chemotherapy

Other

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 outcomes

  1. 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)

Secondary outcomes

  1. Progress free survival(PFS)

    Time frame: 3 years, year 3

    The duration from the beginning of treatment to cancer recurrence or progression

  2. Overall survival(OS)

    Time frame: 5 years, year 5

    The duration from the beginning of treatment to patient death

Study contacts

Contact information is provided by the study sponsor or research team.

Peihua Lu

CONTACT

[email protected]

0510-85350835

Sponsors and collaborators

Lead sponsor

Wuxi People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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