Hepatocellular Carcinoma Clinical Trial
Official title:
Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
| NCT number | NCT03232593 |
| Other study ID # | ML39313 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 29, 2017 |
| Est. completion date | August 12, 2022 |
| Verified date | August 2022 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.
| Status | Completed |
| Enrollment | 1758 |
| Est. completion date | August 12, 2022 |
| Est. primary completion date | August 12, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Participants who are administered with atezolizumab for the locally approved indications Exclusion Criteria: - Participants with a known hypersensitivity to atezolizumab or to any of the excipients |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Donga Uni Medical Center; Pulmonary | Busan | |
| Korea, Republic of | Dongnam Inst.of Radiological & Medical Sciences | Busan | |
| Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
| Korea, Republic of | Inje university Haeundae Paik Hospital | Busan | |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Pusan University Hospital | Busan | |
| Korea, Republic of | Pusan University Hospital; Hemato-oncology | Busan | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Keimyung University Dongsan Hospital; Pulmonology | Daegu | |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | Kyungpook National University Medical Center | Daegu | |
| Korea, Republic of | Konyang University Hospital | Daejeon | |
| Korea, Republic of | Gangneung Asan Hospital | Gangwon-do | |
| Korea, Republic of | Hallym University Medical Center Chuncheon Sacred Heart Hospital | Gangwon-do | |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Gangwon-do | |
| Korea, Republic of | Bucheon St Mary's hospital | Gyeonggi-do | |
| Korea, Republic of | CHA Bundang Medical Center | Gyeonggi-do | |
| Korea, Republic of | Hallym University Sacred Heart Hospital | Gyeonggi-do | |
| Korea, Republic of | Korea University Ansan Hospital | Gyeonggi-do | |
| Korea, Republic of | Soonchunhyang University Bucheon Hospital | Gyeonggi-do | |
| Korea, Republic of | St. Vincent's Hospital | Gyeonggi-do | |
| Korea, Republic of | Uijeongbu St. Mary's Hospital | Gyeonggi-do | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Gyeongsangnam-do | |
| Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital | Hwaseong Si | |
| Korea, Republic of | Chonbuk National University Hospital | Jeollabuk-do | |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Jeollanam-do | |
| Korea, Republic of | Wonkwang University School of Medicine & Hospital | Jeonlabuk-do | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Borame Medical Center | Seoul | |
| Korea, Republic of | ChungAng University Hospital | Seoul | |
| Korea, Republic of | Eunpyeong St. Mary's Hoapital | Seoul | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital; Urology | Seoul | |
| Korea, Republic of | Gangdong Kyung Hee University Hospital | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Hanyang University Medical Center | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences | Seoul | |
| Korea, Republic of | Korea Uni Anam Hospital; Internal Medicine | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Centre; Division of Hematology/Oncology | Seoul | |
| Korea, Republic of | Seoul St Mary's Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System; Oncology | Seoul | |
| Korea, Republic of | Soonchunhyang University Hospital | Seoul | |
| Korea, Republic of | SoonChunHyang University Hospital Seoul | Seoul | |
| Korea, Republic of | VHS Medical Center | Seoul | |
| Korea, Republic of | Yeouido St. Mary's Hospital | Seoul | |
| Korea, Republic of | Ulsan University Hosiptal | Ulsan | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju-Si | |
| Korea, Republic of | Pusan National University Yangsan Hospital; hemato-oncology | Yangsan |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Approximately 6 years | ||
| Secondary | Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Approximately 6 years | ||
| Secondary | Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1 | Approximately 6 years | ||
| Secondary | Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1 | Approximately 6 years | ||
| Secondary | Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1 | Approximately 6 years |
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