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RECRUITING
NCT05378334
NA

Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Sponsor: Guangzhou University of Traditional Chinese Medicine

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China