Phase
Condition
Cancer
Treatment
Intratumoral Injection of Chemotherapy
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged 18-75 years;
Subjects must have histologically- or cytologically-confirmed diagnosis of advancedsolid tumor(s) and have progressed on or is not eligible for available standardtherapy;
Subjects have at least one measurable lesion according to Response EvaluationCriteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10mm, 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 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;
Voluntarily participated in this study, signed the informed consent form, had goodcompliance, and cooperated with the follow-up.
Exclusion
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'tbe guaranteed to complete a full treatment cycle;
Patients with fungal, bacterial, viral or other uncontrollable infections orrequiring four-level isolation treatment.
HIV, HBV and HCV positive;
Patients with diseases of the central nervous system or autoimmune central nervoussystem lesions, Including stroke, epilepsy, dementia;
Patients have myocardial infection, cardiac angiography or stents, active angina orother obvious clinical symptoms, or have cardiopathic asthma or cardiovascularlymphocytic infiltrates,within 12 months;
Patients are on anticoagulation or have severe coagulopathy (APTT>70);
Patients in any condition requiring systemic treatment with corticosteroids or otherimmunosuppressive agents within 2weeks prior to investigational drug administration;
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;
Subjects in other conditions that are considered unsuitable for this study by theinvestigator.
Study Design
Study Description
Connect with a study center
Wuxi People's Hospital
Wuxi, Jiangsu 214043
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.