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

Last updated: May 24, 2024
Sponsor: Wuxi People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

Intratumoral Injection of Chemotherapy

Clinical Study ID

NCT06430515
KY23197
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged 18-75 years;

  2. Subjects must have histologically- or cytologically-confirmed diagnosis of advancedsolid tumor(s) and have progressed on or is not eligible for available standardtherapy;

  3. 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);

  4. ECOG score of 0-2, lifespan > 12 weeks;

  5. 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;

  6. Voluntarily participated in this study, signed the informed consent form, had goodcompliance, and cooperated with the follow-up.

Exclusion

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'tbe guaranteed to complete a full treatment cycle;

  3. Patients with fungal, bacterial, viral or other uncontrollable infections orrequiring four-level isolation treatment.

  4. HIV, HBV and HCV positive;

  5. Patients with diseases of the central nervous system or autoimmune central nervoussystem lesions, Including stroke, epilepsy, dementia;

  6. Patients have myocardial infection, cardiac angiography or stents, active angina orother obvious clinical symptoms, or have cardiopathic asthma or cardiovascularlymphocytic 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 otherimmunosuppressive agents within 2weeks prior to investigational drug administration;

  9. 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;

  10. Subjects in other conditions that are considered unsuitable for this study by theinvestigator.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Intratumoral Injection of Chemotherapy
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214043
    China

    Active - Recruiting

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