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The purpose of this multicenter, dual-cohort, prospective real-world study is to explore the efficacy and safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients.
The efficacy and safety of transarterial chemoembolization (TACE) combined with penpulimab and anlotinib in the treatment of advanced hepatocellular carcinoma (HCC) remain unknown. This is a multicenter, dual-cohort, prospective real-world study with patients receiving normal clinical care. Patients in cohort I will receive TACE combined with penpulimab and anlotinib (TACE-A-A Cohort), and patients in cohort II will just receive penpulimab and anlotinib (A-A Cohort). The primary endpoints of this study are the efficacy of penpulimab and anlotinib combined with or without TACE in advanced HCC patients. While the secondary endpoints include the safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients. The results will provide further evidence for the clinical practice and the design of future trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I（TACE-A-A Cohort） | Experimental | Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment. |
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| Cohort II (A-A Cohort) | Experimental | Patients will receive penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE+penpulimab+anlotinib vs. penpulimab+anlotinib | Drug | Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Time from initiation of either combination therapy to tumor progression according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria or death from any cause. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | The proportion of patients with complete response (CR) and partial response (PR) according to the mRECIST criteria. | 2 years |
| Overall survival (OS) | The time from initiation of either regimen of combination therapy to all-cause death. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Dong Zhu, MD | Contact | 86-25-83262224 | zhuhaidong9509@163.com | |
| Ri Li, MS | Contact | 86-25-83262224 | qmjk_xsj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Patients in cohort I will receive TACE combined with penpulimab and anlotinib (TACE-A-A Cohort), and patients in cohort II will just receive penpulimab and anlotinib (A-A Cohort).
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| up to 5 years |
| Adverse effects | Adverse event (AE)，treatment emergent adverse event(TEAE)，serious adverse event (SAE) | 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |