The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors

Launched by WUXI PEOPLE'S HOSPITAL · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver chemotherapy directly into tumors for patients with advanced solid cancers. The method involves using a fine needle, guided by imaging techniques like CT scans or ultrasounds, to inject chemotherapy drugs such as cisplatin or oxaliplatin directly into the tumor. The goal is to see how effective and safe this approach is for patients who have not responded to standard treatments or are not eligible for them.

To participate in this trial, you need to be between 18 and 75 years old and have a confirmed diagnosis of an advanced solid tumor that has progressed despite previous treatments. You should have at least one measurable tumor that can be evaluated during the study. Participants will be monitored closely throughout the trial, and they must agree to use reliable birth control methods if they are of childbearing age. This study aims to provide more options for patients with difficult-to-treat cancers, and it is currently looking for volunteers to join.

Gender

ALL

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.