Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT05378334

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

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Actively Recruiting

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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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Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients | DecenTrialz