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This is a prospective, multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of transarterial chemoembolization (TACE) combined with a triple oral cocktail regimen versus TACE combined with targeted therapy plus immunotherapy as first-line treatment for unresectable hepatocellular carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: apatinib + camrelizumab + TACE | Active Comparator | Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure. |
|
| Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE | Experimental | Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib: 250m, po, QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. OS will be assessed in the intention-to-treat (ITT) population, which includes all randomized participants. | Up to ~4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first. Tumor progression will be assessed according to the RECICL criteria and the mRECIST criteria by investigators and a blinded independent radiology committee (BIRC) in the ITT population. | Up to ~2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Camrelizumab |
| Drug |
Camrelizumab: 200mg, iv, Q3W |
|
| TACE | Device | TACE if necessary |
|
| Thalidomide (drug) | Drug | Thalidomideļ¼50-75mg, PO, qn; |
|
| Capecitabine | Drug | Capecitabine: 500mg, PO, bid |
|
| Compound cantharides capsule | Drug | Compound cantharides capsule: 750mg, PO, tid |
|
| Time to Progression (TTP) | Time to progression is defined as the time from randomization to disease progression that is no longer amenable to transarterial chemoembolization (TACE failure or refractoriness), as assessed according to RECICL and mRECIST criteria in the ITT population. | Up to ~2 years |
| Objective Response Rate (ORR) | Objective response rate is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) after treatment initiation. Tumor response will be assessed according to RECICL and mRECIST criteria by investigators and the BIRC in the ITT population. | Up to ~2 years |
| Duration of Response (DOR) | Duration of response is defined as the time from the first documented CR or PR to disease progression or death from any cause, whichever occurs first. DOR will be assessed according to RECICL and mRECIST criteria in the ITT population. | Up to ~2 years |
| Health-Related Quality of Life (HRQoL) | Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). | Up to ~2 years |
| 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 |
|---|---|
| C553458 | apatinib |
| C000631724 | camrelizumab |
| D013792 | Thalidomide |
| D004364 | Pharmaceutical Preparations |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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