Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

NCT ID: NCT05378334

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ICI

Intervention Type DRUG

PD-1 inhibitors selected by clinicians based on patients' condition

Chemotherapy

Intervention Type DRUG

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.

Bone-protecting and Mass-dispersesing Decoction

Intervention Type DRUG

Chinese Herbal Formula,also named as HGXJT

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.

Group Type PLACEBO_COMPARATOR

ICI

Intervention Type DRUG

PD-1 inhibitors selected by clinicians based on patients' condition

Chemotherapy

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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ICI

PD-1 inhibitors selected by clinicians based on patients' condition

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Bone-protecting and Mass-dispersesing Decoction

Chinese Herbal Formula,also named as HGXJT

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Haibo Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haibo Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjie Zhao, Dr

Role: CONTACT

8602081887233 ext. 34830

Facility Contacts

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Haibo Zhang, Professor

Role: primary

References

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Other Identifiers

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2021KT0613

Identifier Type: -

Identifier Source: org_study_id

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