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Study Overview

Lead Institution：

A hospital in China · Department of Oncology

Study Type

Prospective · Single-arm · Open-label

Class III therapeutic medical device registration clinical trial (China)

Study Population

Patients with imaging-visible, needle-accessible solid tumors

Total number of tumors ≤ 10

ECOG performance status ≤ 2

200-patient clinical trial of a medical device — the Intratumoral Chlorine Dioxide (ClO₂)

Primary Endpoint

Imaging-confirmed complete response (CR) rate assessed at 30–45 days after treatment,

with a target CR rate of ≥95%.

Secondary Endpoints

• ≥ 30% reduction in tumor volume within 1 hour after injection (ultrasound); • Improvement in cancer-related pain, heart rate, and quality-of-life indicators; • Reduction in inflammatory markers on routine blood tests

Treatment Method

Intratumoral injection of 2% chlorine dioxide working solution

Ultrasound- or CT-guided

Once every 7 days, for a total of 4 treatments

Intravenous sedation only; no general anesthesia required

Procedure comparable to image-guided tumor biopsy

📄 Pre-Registration Form for Intratumoral Chlorine Dioxide Ablation Clinical Trial

(For a Hospital in China)

Note:

This form is for pre-registration only. It is used to evaluate preliminary eligibility and to notify you when the clinical study officially begins.

Pre-registration does not guarantee enrollment or constitute a medical commitment.

1. Basic Information

Gender
Male
Female
Primary Language Ability
English
Chinese
Other

2. Tumor Information

Tumor Locations(check all that apply)
Number of Tumors
1–3
4–6
7–10
>10 (>10 not eligible for this study)
Brain Tumor Present?
No
Yes (Not included at this stage)
Largest Tumor Size
<3 cm
3–5 cm
5–10 cm
>10 cm
Tumor Accessibility
Palpable
Image-guided only (CT/MRI/Ultrasound)

3. Medical History

Current Treatment(check all that apply)
Severe Heart/Lung/Liver/Kidney Disease?
Able to Complete 4 Injection Sessions in 30 Days?
Yes
No

4. Knowledge Acknowledgement


(All items must be checked)

5. Participation Interest

Multi choice
Preferred Contact Method
Phone /WhatsApp
Email

6. Upload Recent Diagnostic Reports

Please upload your most recent medical reports (if available):

• Imaging: CT / MRI / PET-CT

• Pathology report

• Ultrasound (for superficial tumors)

• Any relevant diagnostic document

Please upload no more than 5 files.

7. Privacy Statement

I understand that:

  • This form is for pre-registration only and does not guarantee study enrollment.

  • My information will be used solely for future contact regarding this study.

  • My data will be protected under Chinese and international privacy regulations.

  • I may request deletion of my information at any time.

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