Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- (Disease control rate assessed by investigators) DCR (CR+PR+SD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Combination Group
Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.
HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year.
干预措施: ICI (Drug)
Combination Group
Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.
HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year.
干预措施: Chemotherapy (Drug)
Combination Group
Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.
HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year.
干预措施: Bone-protecting and Mass-dispersesing Decoction (Drug)
Control group
Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.
Placebo: 1 dose daily, until tumor progression or accumulation for 1 year.
干预措施: ICI (Drug)
Control group
Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.
Placebo: 1 dose daily, until tumor progression or accumulation for 1 year.
干预措施: Chemotherapy (Drug)
Control group
Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.
Placebo: 1 dose daily, until tumor progression or accumulation for 1 year.
干预措施: Placebo (Drug)
结局指标
主要结局
(Disease control rate assessed by investigators) DCR (CR+PR+SD)
时间窗: 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.
DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).
次要结局
- ORR(Objective response rate)(From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months)
- Progression-free survival (PFS)(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)(From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.)
研究者
Haibo Zhang
Professor
Guangzhou University of Traditional Chinese Medicine