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

NCT ID: NCT02961998

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Celecoxib group

Patients were treated with sorafenib taking capsules celecoxib (Celebrex) at the same time, 200mg/day, last 6 months

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

Patients from experimental group will take celecoxib, except for sorafenib

Sorafenib

Intervention Type: DRUG

Each group will receive sorafenib as basic treatment.

Control group

Patients take sorafenib only.

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Each group will receive sorafenib as basic treatment.

Interventions

Celecoxib

Patients from experimental group will take celecoxib, except for sorafenib

Intervention Type: DRUG

Sorafenib

Each group will receive sorafenib as basic treatment.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhongguo Zhou

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minshan Chen

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

References

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.

Reference Type: DERIVED

PMID: 32509392 (View on PubMed)

Other Identifiers

2016-FXY-006

Identifier Type: -

Identifier Source: org_study_id