DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

Information source: Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma

Intervention: sustained released 5-FU and sustained released cisplatin (Drug); sustained released 5-FU (Drug); TACE (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Eastern Hepatobiliary Surgery Hospital

Official(s) and/or principal investigator(s):
Shen Feng, MD., Study Chair, Affiliation: Eastern Hepatobiliary Surgery Hospital

Overall contact:
Feng Xu, MD., Phone: 86-21-25070773, Email: victorf2255@hotmail.com

Summary

Hepatectomy is still the most important treatment for HCC. High recurrence rate mostly influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who cannot accept R0 resection. Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection. According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.

Clinical Details

Official title: Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-Term Recurrence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: disease free survival

Secondary outcome: overall survival

Detailed description: 150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50 cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All patients will accepted TACE 30 days after liver resection. We will follow up all patients until they are dead or missed connected. Related adverse reaction will be recorded. Total survival time (TST) and disease free survival time (DFST) will be calculated too. At the end of the study we will compare the difference of adverse reaction, complication, TST and DFST between the 3 groups. According to the result we will estimate these drugs' antitumor effect and safety.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. tumor >5cm; 2. multiple tumor located in one liver lobe; 3. margin of tumor is not clear; 4. cutting edge to tumor <1cm; 5. portal vein branch invasion; 6. without extra-liver metastasis; 7. patient's liver function and condition is able to accept hepatectomy. Exclusion Criteria: 1. single tumor <=5cm; 2. multiple tumor located more than in one liver lobe; 3. margin of tumor is clear; 4. cutting edge to tumor >=1cm; 5. portal vein stem invasion 6. extra-liver metastasis; 7. patient's liver function and condition cannot accept hepatectomy.

Locations and Contacts

Feng Xu, MD., Phone: 86-21-25070773, Email: victorf2255@hotmail.com

Eastern Hepatobiliary Surgery Hospital, Shanghai, Shanghai 200438, China; Recruiting
Yangqing Huang, Phone: 86-21-65564166-75493, Email: erdyhuang@vip.163.com
Jiamei Yang, MD., Phone: 86-21-25070808
Additional Information

Starting date: December 2008
Last updated: January 6, 2009

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017