Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

For patients with selected T1 or T2; N0; M0 disease.

Standard treatment options:

• Surgery: Resection of localized hepatocellular cancer varies from segmental resection to trisegmental (80% of liver) resection. In series of carefully selected patients, partial hepatectomy has resulted in a 5-year survival of 30% to 40%, with median survivals approaching 3 years.[1] In a retrospective study of patients with intrahepatic cholangiocarcinoma, hepatic resection demonstrated a 5-year survival of 23% and a tumor-free survival of 11%.[2][Level of evidence: 3iiiDii] Hepatic carcinoma is frequently multifocal and may involve multiple sites throughout the liver at the time of exploration, even when a dominant mass is found on preoperative assessment. Preoperative assessment should also include a search for extrahepatic metastases, since this condition will also preclude the planned hepatic resection. Intraoperative ultrasound assessment of the liver often finds satellite or second lesions.[3] Resection that involves more than a nonanatomic wedge of liver is poorly tolerated and leads to a high mortality rate in patients with severe cirrhosis. Severe cirrhosis may be a contraindication to major hepatic resection but may not contraindicate hepatic transplantation.[4-7] Hepatic transplantation for hemangioendothelioma, fibrolamellar hepatocellular carcinoma, and small (<5 cm) hepatocellular carcinoma in patients with or without cirrhosis has been associated with 5-year survivals of 20% to 30%.[8][Level of evidence: 3iiiA];[9]

Treatment options under clinical evaluation:

• Chemotherapy or biologic therapy: Because of the high proportion of patients who experience relapse following surgery for localized hepatic cancer, adjuvant approaches have been employed using chemoembolization, regional arterial infusion of the liver or systemic therapy with chemotherapeutic agents. One randomized trial of 43 patients suggested improved survival with adjuvant injection of a single dose (1,850 MBq) of I-131 lipiodol via the hepatic artery. Median disease-free survival in the treatment group was 57 months compared to 13.6 months in the group that did not receive treatment beyond resection (P = .037).[10][Level of evidence: 1iiA,1iiB] Lipiodol was nontoxic, but required thyroid suppression before and after surgery. Enrollment in this trial was prematurely terminated because of early differences in survival between the treatment and control arms. Therefore, the results must be considered preliminary and will require confirmation.

  Adoptive immunotherapy with interleukin-2 and anti-CD3 activated autologous lymphocytes was found to have lengthened recurrence-free survival, but not overall survival, in one study.[11][Level of evidence: 1iiDiv] Localized recurrences in the liver may occasionally be successfully treated by re-resection.[12,13]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with localized resectable adult primary liver cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Fong Y, Sun RL, Jarnagin W, et al.: An analysis of 412 cases of hepatocellular carcinoma at a Western center. Ann Surg 229 (6): 790-9; discussion 799-800, 1999.  [PUBMED Abstract]
   
   
2. Ohtsuka M, Ito H, Kimura F, et al.: Extended hepatic resection and outcomes in intrahepatic cholangiocarcinoma. J Hepatobiliary Pancreat Surg 10 (4): 259-64, 2003.  [PUBMED Abstract]
   
   
3. Karl RC, Choi J, Yeatman TJ, et al.: Role of Computed Tomographic Arterial Portography and Intraoperative Ultrasound in the Evaluation of Patients for Resectability of Hepatic Lesions. J Gastrointest Surg 1 (2): 152-158, 1997.  [PUBMED Abstract]
   
   
4. Starzl TE, Koep LJ, Weil R 3rd, et al.: Right trisegmentectomy for hepatic neoplasms. Surg Gynecol Obstet 150 (2): 208-14, 1980.  [PUBMED Abstract]
   
   
5. Nagorney DM, van Heerden JA, Ilstrup DM, et al.: Primary hepatic malignancy: surgical management and determinants of survival. Surgery 106 (4): 740-8; discussion 748-9, 1989.  [PUBMED Abstract]
   
   
6. MacIntosh EL, Minuk GY: Hepatic resection in patients with cirrhosis and hepatocellular carcinoma. Surg Gynecol Obstet 174 (3): 245-54, 1992.  [PUBMED Abstract]
   
   
7. Hemming AW, Cattral MS, Reed AI, et al.: Liver transplantation for hepatocellular carcinoma. Ann Surg 233 (5): 652-9, 2001.  [PUBMED Abstract]
   
   
8. Pichlmayr R, Weimann A, Oldhafer KJ, et al.: Appraisal of transplantation for malignant tumours of the liver with special reference to early stage hepatocellular carcinoma. Eur J Surg Oncol 24 (1): 60-7, 1998.  [PUBMED Abstract]
   
   
9. Yamamoto J, Iwatsuki S, Kosuge T, et al.: Should hepatomas be treated with hepatic resection or transplantation? Cancer 86 (7): 1151-8, 1999.  [PUBMED Abstract]
   
   
10. Lau WY, Leung TW, Ho SK, et al.: Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: a prospective randomised trial. Lancet 353 (9155): 797-801, 1999.  [PUBMED Abstract]
    
    
11. Takayama T, Sekine T, Makuuchi M, et al.: Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet 356 (9232): 802-7, 2000.  [PUBMED Abstract]
    
    
12. Nakajima Y, Ko S, Kanamura T, et al.: Repeat liver resection for hepatocellular carcinoma. J Am Coll Surg 192 (3): 339-44, 2001.  [PUBMED Abstract]
    
    
13. Neeleman N, Andersson R: Repeated liver resection for recurrent liver cancer. Br J Surg 83 (7): 893-901, 1996.  [PUBMED Abstract]
    
    

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