Lung Cancer
Conditions
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 treatment for stage IV driver gene-negative non-small cell lung cancer.
Interventions
DRUGToluenesulfonamide (PTS) Intratumoral Injection
intratumoral injection of toluenesulfonamide(PTS) to oligo lesions
Sponsors
Zhou Chengzhi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 3 years | Proportion of target lesions stabilized after two courses of first-line chemoimmunotherapy standard therapy combined with and without PTS intratumoral injection, with tumor volume reduction to achieve complete remission (CR) and partial remission (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median progression-free survival(mPFS) | 3 years | Time from receipt of first-line chemoattenuated standard of care in combination with or without PTS intratumoral injection until first objectively documented disease progression or death from any cause (whichever occurs first) |
| Median overall survival(mOS) | 3 years | Time from receipt of first-line chemoattenuated standard of care in combination with or without PTS intratumoral injection until death from any cause (whichever occurs first) |
Countries
China
Contacts
Primary ContactChengzhi Zhou, doctor
Backup ContactXiaohong Xie, master
Outcome results
None listed