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Purpose:explore the effectiveness and safety of transarterial chemoembolization (TACE) plus Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona stage C hepatocellular carcinoma (HCC)
Thhis is a non-randomized, open, single-arm clinical study. patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle, until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.
Number of patients: 66 patients End points:primary end points:safety 、objective response rate,disease control rate,progression free overall survival,second end point :overall survival Include criteria:
Exclude criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTACE-HAIC(oxaliplatin and raltitrexed) | Experimental | Patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cTACE-HAIC | Drug | transarterial chemoembolization (TACE) plus Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona stage C hepatocellular carcinoma (HCC) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate, ORR | The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate | 6 months |
| Disease control rate, DCR | disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate | 6 months |
| Progression free overall survival,PFS | PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, OS | overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment | 25 months |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Zhu | Contact | 86-01088196059 | drzhuxu@163.com | |
| Baojiang Liu | Contact | 86-01088196059 | lbjjrk@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xu Zhu | Peking University Cancer Hospital & Institute | Principal Investigator |
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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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|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |