Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail

Hepatocellular Carcinoma Clinical Trial

Official title:

Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961998
• Other study ID #: 2016-FXY-006
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the popularity of health examination, most patients were diagnosed as HCC in advanced stages so far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced HCC. However, sorafenib need long-term medication, and will bring a series of side effects, including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling, rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's quality of life.Besides, this side effects appeared to be dose-related.When severe HFS happened, sorafenib need to reduce dosage or discontinue administration, which could seriously affect the patient's survival. Therefore, investigators designed this prospective randomized controlled study to explore preventive effect of celecoxib for sorafenib related HFS, the influence on the quality of life in patients with, and also the synergistic anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life and tumor control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1.Diagnosed with HCC according to the Primary liver cancer diagnosis and treatment practices published by the Ministry of Health in 2011 China

• 2.A Karnofsky Performance Status (KPS) score =70 points

• 3.Age between 18 and 70 years

• 4.Child-Pugh classA or B (class B patients had scores no greater than 7 points). In addition, the baseline laboratory tests had to meet the following criteria: white blood cells (WBCs) =1.5 × 109/L, platelets =50 × 109/L, hemoglobin =80 g/L, serum aspartate transaminase (AST) and alanine transaminase (ALT) = 2 x the upper limit of normal (ULN), serum creatinine = 1.5 x ULN, an international normalized ratio (INR)<1.5 or prothrombin time < the ULN + 4 seconds, albumin =30 g/L, and total bilirubin =34mmol/L

• 5.Patients with advanced hepatocellular carcinoma who failed first-line therapy with surgery,radiofrequency ablation

Exclusion Criteria:

• 1.Pugh Child-Pugh Grade C, or with massive ascites or had a history of hepatic encephalopathy, or previous history of gastrointestinal bleeding

• 2.Poor general condition or cachexia

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hand-Foot Syndrome
• Hepatocellular Carcinoma

Intervention

Drug:
• Celecoxib
Patients from experimental group will take celecoxib, except for sorafenib
• Sorafenib
Each group will receive sorafenib as basic treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of participants with clinically definite Sorafenib-related Hand Foot Syndrome		within the first 6 months after sorafenib administration
Secondary	Overall survival		one year