Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2018-05-01
2019-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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Para-toluenesulfonamide Injection (PTS)
Investigational product
Para-toluenesulfonamide Injection (PTS)
Intratumoral injection
Interventions
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Para-toluenesulfonamide Injection (PTS)
Intratumoral injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject's performance status is classified as Grade 0 to Grade 3. Estimated survival time should be longer than 6 months of time.
* Physical examinations show no serious functional disorders of the heart, liver, kidneys, or blood.
* Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3 months recovery time is required before treating with this investigational drug.
* Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not suitable for surgery, or refuses to be operated.
* Subject should show lobular atelectasis with either complete or incomplete obstruction of the bronchi.
* Physical examinations should show no functional disorders of the heart, liver, kidneys, central nervous system, and blood.
* Subject performance status to be classified from Grade 0 to Grade 3, who can tolerate the fiberoptic bronchoscopy treatments.
* In-patient is preferred. When subject is in satisfactory conditions, the out Cpatient can also be enrolled in this trial.
* Two to three months recovery time is required for the subject has just received radio or chemotherapy.
* Emergency request, subjects with serious lobular atelectasis and almost complete obstruction of the bronchi.
* With the aid of a tracheal intubation and the help of the respirator, PTS may be intraumorally injected into the obstructed lesion via fiberoptic bronchoscopy outside of the tube, alongside of the intubation.
Exclusion Criteria
* Subjects with serious functional disorders of the heart, liver, kidneys, or blood will be excluded.
* Subjects who do not want to participate in the trial will not be used as test subjects.
* Subject does not agree to participate.
* Subject performance status is Grade 4, and the one who does not want to tolerate the discomfort of the PTS treatments via fiberoptic bronchscopy.
18 Years
ALL
No
Sponsors
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PTS International Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nan-Shan Zhong
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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US-01
Identifier Type: -
Identifier Source: org_study_id
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