Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy

Официальное название

A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer

Обзор

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.

Вмешательства

• Препарат Toluenesulfonamide (PTS) Intratumoral Injection
  intratumoral injection of toluenesulfonamide(PTS) to oligo lesions

Первичные конечные точки

• Objective response rate(ORR) [Срок оценки: 3 years]

Вторичные конечные точки (2)

• Median progression-free survival(mPFS) [Срок оценки: 3 years]
• Median overall survival(mOS) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06607796 · CROC-24-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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