A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction

NCT03448146 | Completed Phase 3

• 1 other identifier: PTS302
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC tumor severe obstruction.

Conditions

Nsclc

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  The objective response rate of target lesions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.

  30 days after the last treatment

• Improvement rate of luminal obstructions

  The improvement rate of luminal obstructions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.

  30 days after the last treatment

Secondary Outcomes (7)

• Change in FVC

  30 days after the last treatment

• Change in FEV1/FVC

  30 days after the last treatment

• Change in BDI score

  30 days after the last treatment

• Change in pleural effusion

  30 days after the last treatment

• Change in ECOG performance status

  30 days after the last treatment

Study Arms (1)

Para-Toluenesulfonamide

EXPERIMENTAL

1. .The dose of PTS injected into multiple points in a single tumor was about 0.1-1.0 mL, and the appropriate specific doses were kept within the tumor without leakage. An appropriate low dose could be given firstly, and the following doses could be adjusted based on the response of patient and the tumor. 2. . In general, the daily dose of PTS injected into a single tumor was no more than 5mL, and the daily dose of PTS was no more than 10mL for each patient. The injection was provided 2-3 times a week, with 2 weeks as a cycle of treatment. No less than 4 times of PTS treatment were recomended for the first cycle of treatment, and for other cycles of treatment, the number of PTS injections could be adjusted appropriately based on the condition of the patient.

Drug: Para-Toluenesulfonamide

Interventions

Para-Toluenesulfonamide DRUG

Also known as: PTS

Para-Toluenesulfonamide

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female inpatients, aged 18 to 83 years old.
• Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: ≥1/2 trachea is obstructed by tumor; and/or block ≥2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion \> 0.5 cm.
• Pathologically confirmed lung cancer.
• Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy.
• At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors.
• Blood platelet count ≥ 100,000/mm3.
• Subjects who were able to understand and comply with the trial protocol and give written consent.

You may not qualify if:

• Brain metastases.
• History of cardiovascular diseases, including congestive heart failure \> New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded.
• Severe infections or dysbolism.
• Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators.
• Poor general conditions or cachexia.
• The target lesion had been treated with radiotherapy within 6 months.
• Pregnant or breast-feeding woman.
• Known hypersensitivity to PTS or related compounds.
• Lung cancer lesions not suitable for local treatment.
• Any other reason deemed reasonable by the investigator.

Sponsors & Collaborators

• PTS International Inc.: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Related Publications (1)

• Li SY, Li Q, Guan WJ, Huang J, Yang HP, Wu GM, Jin FG, Hu CP, Chen LA, Xu GL, Liu SZ, Wu CG, Han BH, Xiang Y, Zhao JP, Wang J, Zhou X, Li HP, Zhong NS. Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial. Lung Cancer. 2016 Aug;98:43-50. doi: 10.1016/j.lungcan.2016.05.012. Epub 2016 May 17.

  PMID: 27393505 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

4-toluenesulfonamide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nan Shan Zhong

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 27, 2018
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

CN (1)