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This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Bevacizumab + TACE | Experimental | Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rate | pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review. | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathologic Response (MPR) Rate | MPR rate is defined as the proportion of participants with =<30% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review. | At the time of surgery |
| Relapse-Free Survival (RFS) |
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Inclusion Criteria:
Signed Informed Consent Form available
Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
Diagnosis of HCC confirmed by histology
Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size >5 cm, tumor number >3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).
Up to three tumors, with largest tumor >5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) and/or poor tumor differentiation (Grade 3 or 4)
Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
Child-Pugh A
ECOG PS 0~1
No prior locoregional or systemic treatment for HCC
Negative HIV test at screening
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Bi | Contact | +86 (010)87787100 | beexy1971@163.com | |
| Xiaowu Zhang | Contact | +86 (010)87788502 | zhangxiaowu767@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Bevacizumab | Drug | Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle. |
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| Transarterial chemoembolization (TACE) | Procedure | TACE will be performed by clinical demand. |
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RFS is defined as the time from surgery to the first documented recurrence of disease (intrahepatic or extrahepatic) according to EASL and/or RECIST v1.1, or death from any cause. |
| Surgery to the first documented recurrence of disease (up to approximately 2 years) |
| Event-Free Survival (EFS) | EFS is defined as the time from enrollment to any of the following events (whichever occurs first): disease progression that precludes surgery, as assessed by the investigator according RECIST v1.1; local regional, or distant disease recurrence as measured by EASL and/or RECIST v1.1; or death from any cause. | Enrollment up to approximately 2 years |
| Overall Survival (OS) | OS is defined as the time from enrollment to death from any cause. | Enrollment to death from any cause (up to approximately 5 years) |
| Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0 | Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters. | From the start of treatment to 30 days after surgery |
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | China |
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| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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