Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

Официальное название

Transthoracic Versus Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer: A Prospective, Randomized Controlled Trial

Обзор

The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.

Подробное описание

Ablation therapy has been widely used in the treatment of peripheral lung cancer. Among various ablation techniques, cryoablation has been demonstrated to be therapeutic efficacy with several advantages, including high safety, clear ablation borders, and minimal local pain. With the development of navigational bronchoscopy, pilot study on transbronchial cryoablation for peripheral lung cancer has proved its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term as well as long-term efficacy and safety. This study was designed as a prospective, randomized controlled, multicenter clinical trial. A total of 110 participants will be randomly assigned to either the transbronchial group or the transthoracic group in a 1:1 ratio. The primary endpoint is the complete ablation rate at 12 months post-ablation. Secondary endpoints include technical success rate, complete ablation rate at 6 months post-ablation, local control rate at 1, 2 and 3 years post-ablation, progression-free survival, overall survival, and safety.

Вмешательства

• Устройство Transthoracic cryoablation
  Transthoracic cryoablation will be performed under the guidance of CT.
• Устройство Transbronchial cryoablation
  Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.

Первичные конечные точки

• Complete ablation rate at 12 months [Срок оценки: Twelve months post-ablation]

Вторичные конечные точки (6)

• Technical success rate [Срок оценки: Immediately after Each Operation]
• Complete ablation rate at 6 months [Срок оценки: Six months post-ablation]
• Local control rates at 1, 2 and 3 years postoperatively [Срок оценки: 12, 24, 36 monthspost-ablation]
• Progression-free survival (PFS) [Срок оценки: From the time of treatment to the time of disease progression or death (determined by the one which occurs first), up to 36 months]
• Overall survival（OS） [Срок оценки: From the time of treatment to the time of the patient death, up to 36 months]
• Adverse event [Срок оценки: Twelve months psot-ablation]

Критерии участия

Критерии включения

• Age older than 18 years.
• Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
• The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation.
• Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.

Критерии исключения

• Patients with platelets <70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term.
• Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
• Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever >38.5°C.
• Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term.
• Those with poorly controlled malignant pleural effusions.
• Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\~7d before ablation.
• Eastern Cooperative Oncology Group (ECOG) score >2.
• Combination with other tumors with extensive metastases and an expected survival of <6 months.
• Patients with episodic psychosis.
• Pregnant women, or patients with pregnancy plan during the study period.
• Have participated or are participating in other clinical studies within 30 days.
• Any other condition that the investigator considers inappropriate for participation in this study.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Henan Provincial People's Hospital — Чжэнчжоу
• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• West China Hospital, Sichuan University — Чэнду
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06572540 · AT-RXLD-202401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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