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Trial Title:
The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors
NCT ID:
NCT06430515
Condition:
Intratumoral Injection
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Intratumoral Injection of Chemotherapy
Description:
This project intends to investigate the clinical efficacy of intra-tumoural injection of
chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration
guided by CT or ultrasound in patients with advanced solid cancers to validate the safety
and efficacy.
Arm group label:
Intratumoral Injection of Chemotherapy
Summary:
This project intends to investigate the clinical efficacy of intra-tumoural injection of
chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration
guided by CT or ultrasound in patients with advanced solid cancers to validate the safety
and efficacy.
Detailed description:
Malignant solid tumours including lung and liver cancers are the most common malignant
tumours worldwide and have a very high mortality rate. Currently,the clinical practice
mainly relies on systemic administration of chemotherapeutic agents usually by
intravenous infusion for patients with solid cancer with multiple metastases,but the
overall efficiency is not high.Single or multiple chemotherapeutic agents are infused
intratumourally to increase the local drug concentration in the tumour, improve efficacy
and reduce drug resistance and systemic adverse effects. This project intends to
investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents
(e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound
in patients with advanced solid cancers to validate the safety and efficacy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female aged 18-75 years;
2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced
solid tumor(s) and have progressed on or is not eligible for available standard
therapy;
3. 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);
4. ECOG score of 0-2, lifespan > 12 weeks;
5. 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;
6. Voluntarily participated in this study, signed the informed consent form, had good
compliance, and cooperated with the follow-up.
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't
be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or
requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous
system lesions, Including stroke, epilepsy, dementia;
6. 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;
7. Patients are on anticoagulation or have severe coagulopathy (APTT>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other
immunosuppressive agents within 2weeks prior to investigational drug administration;
9. 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;
10. Subjects in other conditions that are considered unsuitable for this study by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuxi People's Hospital
Address:
City:
Wuxi
Zip:
214043
Country:
China
Status:
Recruiting
Contact:
Last name:
Peihua Lu, MD
Phone:
13621500031
Email:
13625653@qq.com
Start date:
September 1, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Wuxi People's Hospital
Agency class:
Other
Source:
Wuxi People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430515
