NCT05378334 Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
| NCT ID | NCT05378334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou University of Traditional Chinese Medicine |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2022-06-15 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment.
Eligibility Criteria
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.
Contact & Investigator
Haibo Zhang, Professor
PRINCIPAL INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT05378334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05378334 currently recruiting?
Yes, NCT05378334 is actively recruiting participants. Contact the research team at 20209120019@stu.gzucm.edu.cn for enrollment information.
Where is the NCT05378334 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05378334 clinical trial?
NCT05378334 is sponsored by Guangzhou University of Traditional Chinese Medicine. The principal investigator is Haibo Zhang, Professor at Guangdong Provincial Hospital of Traditional Chinese Medicine. The trial plans to enroll 82 participants.
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