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The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatectomy alone | Experimental | Patients in this group will receive hepatectomy alone. |
|
| Neoadjuvant radiotherapy plus hepatectomy | Active Comparator | Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatectomy alone | Procedure | Patients in this group will receive hepatectomy alone. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | From the date of hepatectomy to HCC recurrence or the end of follow-up. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei-Zhong Tang, MD | Cancer Hospital of Guangxi Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University | Nanning | Guangxi | 530021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29543938 | Background | Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847. | |
| 31070690 |
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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 |
|---|---|
| D006498 | Hepatectomy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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Neoadjuvant Radiotherapy
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| Neoadjuvant radiotherapy |
| Radiation |
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy. |
|
| He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250. |
| 29631810 | Background | Kudo M, Ueshima K, Yokosuka O, Ogasawara S, Obi S, Izumi N, Aikata H, Nagano H, Hatano E, Sasaki Y, Hino K, Kumada T, Yamamoto K, Imai Y, Iwadou S, Ogawa C, Okusaka T, Kanai F, Akazawa K, Yoshimura KI, Johnson P, Arai Y; SILIUS study group. Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):424-432. doi: 10.1016/S2468-1253(18)30078-5. Epub 2018 Apr 7. |
| 27317960 | Background | Li N, Feng S, Xue J, Wei XB, Shi J, Guo WX, Lau WY, Wu MC, Cheng SQ, Meng Y. Hepatocellular carcinoma with main portal vein tumor thrombus: a comparative study comparing hepatectomy with or without neoadjuvant radiotherapy. HPB (Oxford). 2016 Jun;18(6):549-56. doi: 10.1016/j.hpb.2016.04.003. Epub 2016 May 7. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |