Actively Recruiting
Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Led by Guangzhou University of Traditional Chinese Medicine · Updated on 2026-03-10
82
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-small cell lung cancer by tissue or cell analysis
- Have bone metastases
- EGFR and ALK genes are wild type
- No prior treatment with PD-1 inhibitors alone or in combination
- No prior antitumor therapy or have not received further treatment after first-line therapy failure
- Performance status score (ECOG) of 2 or less
- Normal liver function: total bilirubin 1.5 times upper normal limit; AST and ALT 2.5 times upper normal limit
- Normal kidney function: serum creatinine 1.5 mg/dl or creatinine clearance 60 ml/min
- At least one measurable tumor lesion
- Provided informed consent and willing to follow treatment and study requirements
You will not qualify if you...
- Unable to complete baseline assessment form
- Have serious illnesses such as uncontrolled infection, severe electrolyte problems, or major bleeding risks
- Pregnant or breastfeeding women
- Have autoimmune diseases, blood disorders, or long-term use of hormones or immunosuppressants
- Have other uncontrolled cancers
- Have severe brain or mental illness affecting self-reporting
- History of organ transplant including bone marrow or stem cell transplant
- Legally incompetent or medical/ethical issues preventing study continuation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
Wenjie Zhao, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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