Status:
UNKNOWN
Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
- Presence of bone metastases.
- EGFR/ALK gene wild type.
- No prior treatment with PD-1 inhibitors (combination or monotherapy)
- Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
- PS score (ECOG) ≤ 2 points
- 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.
- Presence of at least one assessable lesion.
- Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.
Exclusion
- Unable to complete the baseline assessment form
- Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
- Pregnant or lactating women.
- Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
- Combination of other uncontrolled tumors.
- Combination of severe brain or mental illness that affects the patient's ability to self-report.
- Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
- Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05378334
Start Date
June 15 2022
End Date
March 1 2025
Last Update
August 15 2022
Active Locations (1)
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1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China