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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWuxi People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood glucose stress combined with low-dose chemotherapy

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Blood glucose stress combined with low-dose chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relief degree of tumors

It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST1.1)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Progress free survival(PFS)

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

Time frame
3 years, year 3
2

Overall survival(OS)

The duration from the beginning of treatment to patient death

Time frame
5 years, year 5

Other outcomes

Sponsors and contacts

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