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Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Sponsor: Guangzhou University of Traditional Chinese Medicine
Summary
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.
Official title: Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2022-06-15
Completion Date
2028-01-01
Last Updated
2026-03-10
Healthy Volunteers
Yes
Conditions
Interventions
ICI
PD-1 inhibitors selected by clinicians based on patients' condition
Chemotherapy
AP regimen(Pemetrexed 500mg/m2+carboplatin AUC=5,q3w) for non-squamous cancer patientsor or TP regimen(Paclitaxel 175mg/m2+carboplatin AUC=5, or albumin paclitaxel 100mg/m2+carboplatin AUC=5,q3w)for Squamous cancer patients.
Placebo
The particle size and color are similar to the HGXJT, and the smell and taste are close to the HGXJT, and the bacteria test is qualified
Bone-protecting and Mass-dispersesing Decoction
Chinese Herbal Formula,also named as HGXJT
Locations (1)
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China