NCT05378334Recruiting
Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 4 Apr 2022
- Start date
- Jun 2022
- Primary completion date
- Sept 2027
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Diseases
- Lung cancer
- NCT number
- NCT05378334
What you commit to
- Study type: Interventional
- Planned participants: 82
- From Jun 2022 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
Other illness
- Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
- Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
- Combination of severe brain or mental illness that affects the patient's ability to self-report.
Other
- Unable to complete the baseline assessment form
- Pregnant or lactating women.
- Combination of other uncontrolled tumors.
- Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.