NCT05378334

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Guangzhou University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ICI	PD-1 inhibitors selected by clinicians based on patients' condition
DRUG	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.
DRUG	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
DRUG	Bone-protecting and Mass-dispersesing Decoction	Chinese Herbal Formula,also named as HGXJT

Timeline

• Start date: 2022-06-15
• Primary completion: 2027-09-01
• Completion: 2028-01-01
• First posted: 2022-05-18
• Last updated: 2026-03-10

Locations

1 site across 1 country: China