Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer

Официальное название

Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study

Обзор

This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.

Вмешательства

• Устройство Acupuncture
  Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the acupuncture group is combined with acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the press needle trea
• Устройство Sham Comparator
  Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the sham acupuncture group is combined with sham acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of sham acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the sh

Первичные конечные точки

• Objective Response Rate [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred]

Вторичные конечные точки (11)

• Disease Control Rate [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred]
• Progression-Free Survival [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred]
• Overall Survival [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred.]
• Eastern Cooperative Oncology Group Performance Status, ECOG PS [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred]
• GAD-7 [Срок оценки: At 0,4,7,10,13 weeks,6 months from randomization]
• PHQ-9 [Срок оценки: At 0,4,7,10,13 weeks,6 months from randomization]
• Insomnia Severity Index [Срок оценки: At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization]
• Lung Cancer Symptom Scale [Срок оценки: At 0,4,7,10,13 weeks,6,9 months from randomization]
• weight [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred]
• adverse event [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred]
• Duration of immunotherapy [Срок оценки: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used]

Критерии участия

Критерии включения

• Age 18-75 years;
• ECOG/PS score of grade 0-1 and expected survival ≥ 3 months;
• Non-small cell lung cancer AJCC lung cancer staging of stage IIIB-IV, or small cell lung cancer staging of extensive stage;
• PD-L1 immunohistochemistry detection of tumor cell positive proportion score (TPS) <50%;
• Non-small cell lung cancer adenocarcinoma patients do not have EGFR-sensitive mutations, ALK fusions, ROS1 fusions, BRAFV600 mutations, NTRK fusions, RET fusions, MET14 skipping mutations, and amplified gene-driven mutations by genetic testing;
• Patients with no previous systemic therapy/first-line treatment;
• Patients suitable for chemotherapy combined with immunotherapy;
• Traditional Chinese Medicine (TCM) diagnosis of Qi Depression;
• Having at least 1 measurable tumor lesion (diameter > 1cm) or lymph node short diameter ≥ 1.5cm;
• Sign the informed consent form and voluntarily participate in this study.

Критерии исключения

• Combined with other primary malignant tumors;
• Those who have contraindications to immunotherapy after basic assessment of immunotherapy;
• Those with autoimmune diseases or those who need long-term treatment with systemic steroids or immunosuppressants;
• Those with combined serious and uncontrolled primary diseases of heart, cerebrovascular, liver, kidney, hematopoietic system and so on;
• Those with metal allergy or severe fear of needles;
• Those who are pregnant or breastfeeding;
• Those who are unable to cooperate to complete the assessment due to mental disorder, intellectual or language impairment;
• Those with active severe infectious or inflammatory diseases;
• Those who have received acupuncture treatment or other clinical trials within 1 month prior to randomization;
• In the judgment of the investigator, persons who have a concomitant medical condition that seriously jeopardizes the safety of the participant or interferes with the completion of the study, or who are deemed to have other reasons for not being suitable 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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine — Пекин
• Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital — Чанша

Идентификаторы

NCT: NCT06926140 · 2024-195-KY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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