Actively Recruiting
Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy
Led by Zhou Chengzhi · Updated on 2024-09-25
180
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.
CONDITIONS
Official Title
Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and sign the Informed Consent Form
- Age between 18 and 75 years at the time of signing the consent
- Confirmed stage IV driver gene-negative non-small cell lung cancer
- At least one measurable target lesion within 4 weeks before enrollment, except for lesions planned for PTS injection
- Localized injectable lesions in the outer lung area, 5 cm or smaller in diameter, including primary or recurrent lesions
- ECOG performance status score of 0 or 1 within 7 days before treatment
- Stable localized lesions after two courses of first-line chemoimmunotherapy
- Life expectancy of at least 3 months
- Normal liver, kidney, heart function, blood tests, coagulation, and electrolytes
You will not qualify if you...
- Plans for radiotherapy, surgery, or other treatments for the lesion after PTS injection
- Severe heart or lung problems, advanced liver or kidney failure, serious arrhythmia, or hypertension
- Severe bleeding, clotting disorders, infections, or dehydration
- Blood disorders, autoimmune diseases, or liver cirrhosis
- History of severe emphysema or lung damage
- Allergy or contraindication to toluenesulfonamide
- Pregnant, breastfeeding, or planning pregnancy during the study
- Other conditions deemed unsuitable by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510145
Actively Recruiting
Research Team
C
Chengzhi Zhou, doctor
CONTACT
X
Xiaohong Xie, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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