Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06430515

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

Led by Wuxi People's Hospital · Updated on 2024-05-28

200

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18-75 years
  • Histologically or cytologically confirmed diagnosis of advanced solid tumor(s)
  • Have progressed on or are not eligible for available standard therapy
  • At least one measurable lesion according to RECIST 1.1 criteria
  • ECOG score of 0-2 with a lifespan greater than 12 weeks
  • Women of childbearing age with a negative pregnancy test within 7 days before treatment
  • Use of medically recognized contraceptive methods during treatment and for at least 6 months after last dose
  • Voluntary participation with signed informed consent and good compliance
Not Eligible

You will not qualify if you...

  • Diagnosis of central nervous system leukemia
  • White blood cell count greater than or equal to 50 x 10^9/L or rapid disease progression preventing full treatment
  • Uncontrollable fungal, bacterial, viral, or other infections requiring isolation
  • HIV, HBV, or HCV positive
  • Diseases or autoimmune lesions of the central nervous system including stroke, epilepsy, dementia
  • Myocardial infarction, cardiac angiography or stents, active angina, or cardiopathic asthma within 12 months
  • Use of anticoagulation or severe coagulopathy (APTT >70)
  • Systemic corticosteroids or immunosuppressive agents within 2 weeks before investigational drug
  • Serious uncontrolled disease or other conditions unsuitable for study treatment as judged by investigator
  • Other conditions deemed unsuitable for the study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wuxi People's Hospital

Wuxi, Jiangsu, China, 214043

Actively Recruiting

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Research Team

P

Peihua Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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