Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: ICIDrug: ChemotherapyDrug: Bone-protecting and Mass-dispersesing DecoctionDrug: Placebo
- Registration Number
- NCT05378334
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 82
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Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
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Presence of bone metastases.
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EGFR/ALK gene wild type.
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No prior treatment with PD-1 inhibitors (combination or monotherapy)
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Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
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PS score (ECOG) ≤ 2 points
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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.
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Presence of at least one assessable lesion.
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Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Group Chemotherapy 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. Combination Group ICI 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. Control group ICI 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. Combination Group Bone-protecting and Mass-dispersesing Decoction 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. Control group Chemotherapy 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. Control group Placebo 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.
- Primary Outcome Measures
Name Time Method (Disease control rate assessed by investigators) DCR (CR+PR+SD) 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).
- Secondary Outcome Measures
Name Time Method 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 ORR (overall response rate) is defined as sum of complete response (CR) rate and partial response (PR) 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).
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. The time from the date of randomization to the date of disease progression, date of withdraw, or death from any cause, whichever occurs first.
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. The time from the date of randomization to the date of withdraw or date of death from any cause, whichever occurs first.
Trial Locations
- Locations (1)
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China