Clareo Health | Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy
1. 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；
2. Age ≥18 years and ≤75 years at the time of signing the ICF；
3. Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
4. 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；
5. 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；
6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
7. Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
8. Life expectancy ≥ 3 months；
9. Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.
You may not be if
1. Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
2. Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
3. Have severe bleeding, clotting disorders, infections, dehydration, etc;
4. Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
5. History of severe emphysema and pulmonary alveoli;
6. History of drug allergy or contraindication to toluene sulfonamide;
7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
8. The investigators determined that the patients had other conditions that made them unsuitable for enrollment.
