Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Recruiting · NCT05378334 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Bone-protecting and Mass-dispersesing DecoctionChemotherapyICIPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Guangdong Provincial Hospital of Traditional Chinese Medicine - Guangzhou, Guangdong, China