Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Официальное название

Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients

Обзор

This is a double-blind, randomized controlled study evaluating the efficacy and safety of HGXJT in combination with ICI-based standard treatment in lung cancer patients with bone metastases. Enrolled participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment.

Вмешательства

• Препарат ICI
  PD-1 inhibitors selected by clinicians based on patients' condition
• Препарат Chemotherapy
  AP regimen（Pemetrexed 500mg/m2+carboplatin AUC=5,q3w） for non-squamous cancer patientsor or TP regimen（Paclitaxel 175mg/m2+carboplatin AUC=5, or albumin paclitaxel 100mg/m2+carboplatin AUC=5,q3w）for Squamous cancer patients.
• Препарат Placebo
  The particle size and color are similar to the HGXJT, and the smell and taste are close to the HGXJT, and the bacteria test is qualified
• Препарат Bone-protecting and Mass-dispersesing Decoction
  Chinese Herbal Formula,also named as HGXJT

Первичные конечные точки

• (Disease control rate assessed by investigators) DCR (CR+PR+SD) [Срок оценки: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.]

Вторичные конечные точки (3)

• Progression-free survival (PFS) [Срок оценки: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.]
• Overall survival (OS) [Срок оценки: From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.]
• ORR(Objective response rate) [Срок оценки: From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months]

Критерии участия

Критерии включения

• Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
• Presence of bone metastases.
• EGFR/ALK gene wild type.
• No prior treatment with PD-1 inhibitors (combination or monotherapy)
• Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
• PS score (ECOG) ≤ 2 points
• Normal hepatic and renal function.

Normal hepatic function: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value(ULN), serum serum aspartate aminotransferase(AST) \& alanine aminotransferase(ALT) ≤ 2.5 times ULN

Normal renal function: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min.

• Presence of at least one assessable lesion.
• Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.

Критерии исключения

• Unable to complete the baseline assessment form
• Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
• Pregnant or lactating women.
• Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
• Combination of other uncontrolled tumors.
• Combination of severe brain or mental illness that affects the patient's ability to self-report.
• Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
• Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу

Публикации

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Идентификаторы

NCT: NCT05378334 · 2021KT0613

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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