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Clinical study of photodynamic therapy for early airway malignant tumor

Clinical study of photodynamic therapy for early airway malignant tumor

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037938
Enrollment
Unknown
Registered
2020-09-04
Start date
2020-09-30
Completion date
Unknown
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway malignant tumor

Interventions

routine treatment group:Laser, high frequency electrotome, argon plasma coagulation (APC), hard mirror elimination, freezing, airway stents, balloon dilatation and other treatments
PDT treatment group:Laser irradiation was performed for about 20 minutes 48 ~ 72 hours after intravenous infusion of photosensitizer

Sponsors

He'nan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The age of male and female is 18-75 years old (including 18 and 75 years old); 2. Patients with early central lung cancer; primary malignant tumor of trachea; Severe dysplasia of trachea and bronchus should meet the following conditions: malignant tumor or precancerous lesion confirmed by pathology, CT, EBUS, optical coherence tomography (OCT), narrow band imaging (NBI) or fluorescence bronchoscopy (FBI) Bronchoscope (AFB) confirmed that the lesion involved mucosa and submucosa, but not cartilage and adventitia. The length was less than 1 cm and the depth of invasion was less than 1 cm within the scope of bronchoscope. There was no lymph node and distant metastasis. The patient could not tolerate surgery or did not accept surgical treatment. 3. The subjects could tolerate general anesthesia, bronchoscopy and airway therapy; 4. Patients who are fully informed of the purpose and content of the trial agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Porphyria and other diseases aggravated by light; 2. Patients known to be allergic to hematoporphyrins or any excipients; 3. Patients who are being treated with photosensitizer now; 4. Patients scheduled for surgery within 30 days; 5. Patients with ophthalmic diseases who need light examination within 30 days; 6. Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction who can not tolerate bronchoscopy; 7. Patients with obvious coagulation dysfunction; 8. Patients with tumor invasion of large blood vessels, tracheoesophageal tumor penetrating infiltration; 9. Patients with tracheoesophageal fistula, tracheo mediastinal fistula, bronchopleural fistula, and the destruction of bronchial tube wall structure; 10. The patients with tracheal tumor to severe stenosis (> 75%) were not allowed to undergo photodynamic therapy directly; 11. Patients with mixed lesions mainly with Extraductal type; 12. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Improvement rate of stenosis degree;Improvement in lung function;Incidence of postoperative complications;overall survival;progression free survival;

Countries

China

Contacts

Public ContactXiaoju Zhang

He'nan Provincial People's Hospital

zhangxiaoju1010@henu.edu.cn+86 15837101166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026