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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02961998
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):
Zhongguo Zhou, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Celecoxib Drug: Sorafenib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Celecoxib group
Patients were treated with sorafenib taking capsules celecoxib (Celebrex) at the same time, 200mg/day, last 6 months
Drug: Celecoxib
Patients from experimental group will take celecoxib, except for sorafenib

Drug: Sorafenib
Each group will receive sorafenib as basic treatment.

Active Comparator: Control group
Patients take sorafenib only.
Drug: Sorafenib
Each group will receive sorafenib as basic treatment.

Primary Outcome Measures :
  1. Incidence of participants with clinically definite Sorafenib-related Hand Foot Syndrome [ Time Frame: within the first 6 months after sorafenib administration ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02961998

Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Minshan Chen Sun Yat-sen University

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Responsible Party: Zhongguo Zhou, Associate Professor, Sun Yat-sen University Identifier: NCT02961998     History of Changes
Other Study ID Numbers: 2016-FXY-006
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhongguo Zhou, Sun Yat-sen University:
hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Hand-Foot Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Drug Eruptions
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs