Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

March 7, 2026 updated by: Haibo Zhang, Guangzhou University of Traditional Chinese Medicine

Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Haibo Zhang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
  2. Presence of bone metastases.
  3. EGFR/ALK gene wild type.
  4. No prior treatment with PD-1 inhibitors (combination or monotherapy)
  5. Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
  6. PS score (ECOG) ≤ 2 points

  7. 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.

  8. Presence of at least one assessable lesion.
  9. Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.

Exclusion Criteria:

  1. Unable to complete the baseline assessment form
  2. Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
  3. Pregnant or lactating women.
  4. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
  5. Combination of other uncontrolled tumors.
  6. Combination of severe brain or mental illness that affects the patient's ability to self-report.
  7. Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
  8. Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Group

Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.

HGXJT decoction: 1 dose daily, until tumor progression or accumulation for 1 year.
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: Bone-protecting and Mass-dispersesing Decoction
Chinese Herbal Formula,also named as HGXJT
Placebo Comparator: Control group

Standard treatment: 4-6 cycles (3 weeks per cycle) of ICI + chemotherapy followed by ICI maintenance therapy, until tumor progression or at least 1 year.

Placebo: 1 dose daily, until tumor progression or accumulation for 1 year.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Disease control rate assessed by investigators) DCR (CR+PR+SD)
Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).
From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
The time from the date of randomization to the date of disease progression, date of withdraw, or death from any cause, whichever occurs first.
From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Overall survival (OS)
Time Frame: From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.
The time from the date of randomization to the date of withdraw or date of death from any cause, whichever occurs first.
From date of randomization to the date of withdraw or date of death from any cause, whichever occurs first, assessed up to 120 months.
ORR(Objective response rate)
Time Frame: From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months
ORR (overall response rate) is defined as sum of complete response (CR) rate and partial response (PR) rate , according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).
From date of randomization until the date of death or date of withdraw, whichever came first, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Haibo Zhang, Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021KT0613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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