Actively Recruiting
Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours
Led by Wuxi People's Hospital · Updated on 2024-05-08
300
Participants Needed
1
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-75 years
- Histologically or cytologically confirmed diagnosis of advanced solid tumor(s) with progression after or ineligibility for standard therapy
- At least one measurable lesion per RECIST 1.1 criteria (non-nodal lesions 10 mm, nodal lesions 15 mm)
- ECOG performance score of 0-2 and life expectancy over 12 weeks
- Negative pregnancy test within 7 days before treatment for women of childbearing age
- Use of at least one medically recognized contraceptive method during treatment and for 6 months after last dose for women of childbearing age and male patients with partners of childbearing age
- Voluntary participation with signed informed consent, good compliance, and willingness to follow-up
You will not qualify if you...
- Diagnosis of central nervous system leukemia
- White blood cell count 50 10^9/L or rapid disease progression preventing full treatment cycle
- Uncontrollable fungal, bacterial, viral, or other infections or requiring four-level isolation
- Positive for HIV, HBV, or HCV
- Diseases or autoimmune lesions of the central nervous system, including stroke, epilepsy, or dementia
- Myocardial infarction, cardiac angiography or stents, active angina, cardiopathic asthma, or cardiovascular lymphocytic infiltrates within 12 months
- Use of anticoagulation or severe coagulopathy (APTT > 70)
- Systemic corticosteroid or immunosuppressive treatment within 2 weeks before study drug
- COVID-19 infection within 2 weeks before study drug
- Any serious uncontrolled disease or condition making study treatment unsuitable
- Other conditions deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214043
Actively Recruiting
Research Team
P
Peihua Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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