Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
NCT ID: NCT05378334
Last Updated: 2022-08-15
Study Results
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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UNKNOWN
NA
82 participants
INTERVENTIONAL
2022-06-15
2025-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
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.
Bone-protecting and Mass-dispersesing Decoction
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
Yes
Sponsors
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Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Haibo Zhang
Professor
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
Countries
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Central Contacts
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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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