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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICI | Drug | PD-1 inhibitors selected by clinicians based on patients' condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| (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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Zhao, Dr | Contact | 8602081887233 | 34830 | 20209120019@stu.gzucm.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haibo Zhang, Professor | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 28708233 | Background | Proto C, Lo Russo G, Corrao G, Ganzinelli M, Facchinetti F, Minari R, Tiseo M, Garassino MC. Treatment in EGFR-mutated non-small cell lung cancer: how to block the receptor and overcome resistance mechanisms. Tumori. 2017 Jul 31;103(4):325-337. doi: 10.5301/tj.5000663. Epub 2017 Jul 1. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy | 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 | 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 |
|
| Bone-protecting and Mass-dispersesing Decoction | Drug | Chinese Herbal Formula,also named as HGXJT |
|
| 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. |
| 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 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |