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Patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone combined with radiotherapy | Experimental | Pirfenidone: synchronized with RT, 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months Radiotherapy: no limitation, TD≥50Gy (BED/ α/β: 10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month) | Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month) | up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1. | up to 6 month |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guang Han, MD,PhD | Contact | 13886048178 | hg7913@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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|
DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator
| up to 6 month |
| 6 month progression-free-survival (PFS) rate | PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator | up to 6 month |
| Treatment-related adverse events | overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use. | up to 6 month |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |