Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378334
• Other study ID #: 2021KT0613
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: August 2022
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Wenjie Zhao, Dr
• Phone: 8602081887233
• Email: 20209120019[@]stu.gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Disease control rate assessed by investigators) DCR (CR+PR+SD)	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	Progression-free survival (PFS)	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.
Secondary	Overall survival (OS)	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.
Secondary	ORR(Objective response rate)	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