Intratumoral chemotherapy for advanced solid tumors

The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors Through Fine Needle Puncture

This study is testing if injecting chemotherapy directly into tumors can help people with advanced solid tumors who haven't responded to standard treatments feel better and have fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Wuxi People's Hospital (Academic / other)
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT06430515 on ClinicalTrials.gov

What this trial studies

This project investigates the clinical efficacy of intratumoral injection of chemotherapeutic agents, such as cisplatin and oxaliplatin, in patients with advanced solid tumors. The approach involves using fine needle aspiration guided by CT or ultrasound to deliver chemotherapy directly into the tumor, aiming to enhance local drug concentration and reduce systemic side effects. The study focuses on patients who have progressed on or are not eligible for standard therapies, with the goal of validating the safety and efficacy of this method.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed advanced solid tumors who have not responded to or are ineligible for standard therapies.

Not a fit: Patients with early-stage tumors or those who are eligible for standard systemic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with advanced solid tumors, potentially improving outcomes and reducing side effects.

How similar studies have performed: Other studies have shown promise with similar intratumoral chemotherapy approaches, suggesting potential for efficacy in this novel application.

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.

Where this trial is running

Wuxi, Jiangsu

• Wuxi People's Hospital — Wuxi, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Peihua Lu

Conditions Intratumoral Injection; Cancer