Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT05378334
Run by: Guangzhou University of Traditional Chinese Medicine
People needed: 82
Starts: 2022-06-15
Expected to finish: 2028-01-01
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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