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A Phase III Single Arm Trial of PTS (Para toluenesulfonamide Injection) via Bronchoscopy Intervention Intratumoral Injection in Patients with Central Air Way NSCLC Tumor Severe Obstruction

A Phase III Single Arm Trial of PTS (Para toluenesulfonamide Injection) via Bronchoscopy Intervention Intratumoral Injection in Patients with Central Air Way NSCLC Tumor Severe Obstruction

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-12002648
Enrollment
Unknown
Registered
2012-10-30
Start date
2009-10-27
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Non Small Cell lung cancer patients with severe airway obstruction

Interventions

Treatment Group:Intertumoral Administration of PTS

Sponsors

Guangzhou Respiratory Disease Institute, Guangzhou Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male or female in-patients, aged 18 to 83 years old; 2. NSCLC patients with severe airway obstruction;Definition of severe airway obstruction:Trachea: More than 1/2 of Trachea was obstructed by tumor; and/or block more than 2/3 of primary bronchi, right and middle bronchi; 3. lung cancer confirmed by histopathology; 4. With a airway tumor suitable for intratumoral injection via fiberoptic bronchoscope; 5. At least one measurable tumor could be evaluated by imaging examination (fiberoptic bronchoscope, CT, MRI or X-ray) according to the RECIST; 6. LT >=100,000/mm3; 7. Able to understand and comply with protocol and give written consent.

Exclusion criteria

Exclusion criteria: 1. With brain metastases; 2. With cardiovascular disease history: congestive heart-failure >NYHA grade II. Patients with unstable angina pectoris (angina pectoris symptoms occur at rest) or recent angina pectoris (occured in recent 3 months) or with myocardial infarction in recent 6 months must be excluded; 3. Severe uncontrollable infections or dysbolism; 4. Poor hepatic functional reserve or serious hepatocirrhosis, abnormal blood coagulation indicators; 5. Poor general conditions or cachexia; 6. The target tumors have been treated with radiotherapy within 6 months; 7. Pregnancy, breast-feeding women; 8. Known hypersensitivity to PTS or related compounds; 9. Lung cancer focus not suitable for local treatment; 10. Any other reasons deemed reasonable by the investigators.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Pulmonary Function;Overall survival;

Contacts

Public ContactNanshan ZHONG
nanshan@vip.163.com+86 020 86668592

Outcome results

None listed

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