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Trial Title:
Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy
NCT ID:
NCT06607796
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toluenesulfonamide (PTS) Intratumoral Injection
Description:
intratumoral injection of toluenesulfonamide(PTS) to oligo lesions
Arm group label:
Experimental group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510145
Country:
China
Status:
Recruiting
Contact:
Last name:
Chengzhi Zhou, doctor
Phone:
13560351186
Email:
doctorzcz@163.com
Contact backup:
Last name:
Xiaohong Xie, master
Phone:
13632326736
Email:
gyxxh@126.com
Start date:
March 1, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Zhou Chengzhi
Agency class:
Other
Source:
Guangzhou Institute of Respiratory Disease
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06607796
