Status:
RECRUITING
Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy
Lead Sponsor:
Zhou Chengzhi
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 treatme...
Eligibility Criteria
Inclusion
- Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；
- Age ≥18 years and ≤75 years at the time of signing the ICF；
- Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
- At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；
- Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；
- ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
- Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
- Life expectancy ≥ 3 months；
- Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.
Exclusion
- Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
- Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
- Have severe bleeding, clotting disorders, infections, dehydration, etc;
- Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
- History of severe emphysema and pulmonary alveoli;
- History of drug allergy or contraindication to toluene sulfonamide;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- The investigators determined that the patients had other conditions that made them unsuitable for enrollment.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06607796
Start Date
March 1 2024
End Date
December 1 2026
Last Update
September 25 2024
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510145