Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Celecoxib
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, sorafenib, celecoxib
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Celecoxib group
Control group
Arm Description
Patients were treated with sorafenib taking capsules celecoxib (Celebrex) at the same time, 200mg/day, last 6 months
Patients take sorafenib only.
Outcomes
Primary Outcome Measures
Incidence of participants with clinically definite Sorafenib-related Hand Foot Syndrome
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT02961998
First Posted
November 6, 2016
Last Updated
September 7, 2019
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02961998
Brief Title
Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail
Official Title
Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, sorafenib, celecoxib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Celecoxib group
Arm Type
Experimental
Arm Description
Patients were treated with sorafenib taking capsules celecoxib (Celebrex) at the same time, 200mg/day, last 6 months
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients take sorafenib only.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Patients from experimental group will take celecoxib, except for sorafenib
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Each group will receive sorafenib as basic treatment.
Primary Outcome Measure Information:
Title
Incidence of participants with clinically definite Sorafenib-related Hand Foot Syndrome
Time Frame
within the first 6 months after sorafenib administration
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minshan Chen
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32509392
Citation
Chen JC, Wang JC, Pan YX, Yi MJ, Chen JB, Wang XH, Fu YZ, Zhang YJ, Xu L, Chen MS, Zhang RX, Zhou ZG. Preventive effect of celecoxib in sorafenib-related hand-foot syndrome in hepatocellular carcinoma patients, a single-center, open-label, randomized, controlled clinical phase III trial. Am J Cancer Res. 2020 May 1;10(5):1467-1476. eCollection 2020.
Results Reference
derived
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Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail
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