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The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: TACE+Camrelizumab+Apatinib | Experimental | Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE |
|
| Control group: TACE | Active Comparator | TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab: 200mg, iv, Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) by investigator | PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness. | Up to ~2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Up to ~4 years |
| PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
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Inclusion Criteria:
Has a diagnosis of HCC confirmed by radiology, histology, or cytology
-≥18 years
China liver cancer staging: Ib-IIIa
Child-Pugh score ≤6 point
Previous TACE treatment(≤2 times) is permitted
Adequate organ and marrow function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, Doctor | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41734362 | Derived | Zhu HD, Fan WJ, Zhao C, Wang S, Li YL, Jin ZC, Zhang ZW, Guo JH, Cheng HT, Zhang Q, Lu J, Zeng YY, Lv WF, Xu H, Shao HB, Xu WG, Zhao XY, Gu SZ, Lin HL, Zheng WH, Piao LZ, Song YS, Zhao JB, Wang YC, Hou ZG, Sun Y, Guan N, Huang M, Yang WZ, Ji JS, Teng GJ. Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial. J Clin Oncol. 2026 Apr 10;44(11):959-969. doi: 10.1200/JCO-25-01796. Epub 2026 Feb 24. |
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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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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| TACE |
| Device |
TACE if necessary |
|
| Apatinib | Drug | Apatinib: 250m, po, QD |
|
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
| Up to ~2 years |
| Time to untreatable (unTACEable) progression (TTUP) by investigator | TTUP is defined as the time from randomization to Child-Pugh grade C, intrahepatic tumor progression (>50% increase vs baseline), MVI or EHS (diameter>10 mm), and met the JSH criteria for TACE failure/refractoriness. | Up to ~2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |