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Sorafenib Combined With Aspirin to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02748304
Recruitment Status : Terminated (The enrollment of this study was slow. With the approval of lenvatinib in HCC,many patients choose the new drug, so subsequent enrollment may be more difficult.)
First Posted : April 22, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lunxiu Qin, Fudan University

Brief Summary:
The purpose of the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Other: control Drug: sorafenib Drug: aspirin Not Applicable

Detailed Description:

The recurrence of hepatocellular carcinoma(HCC)is the main problem during the treatment. Although some methods such as interferon may be effective in preventing the recurrence, there is still no clear effective approach widely accepted for everyone.

Sorafenib, a kind of tyrosine kinase inhibitor, which inhibiting proliferation and inducing apoptosis of tumor cell by inhibiting the raf/MEK/ERK pathway, and anti-angiogenesis by targeting Vascular Endothelial Growth Factor Receptor(VEGFR), has now become the standard treatment of advanced HCC patients. Although the STORM studies have shown that adjuvant sorafenib for such patients did not significantly affect recurrence-free survival, time to recurrence, or overall survival. The patients recruiting in the study were mostly early stage, for middle and late stage patients, whether sorafenib can reduce tumor recurrence after surgical resection and prolong survival remains to be further study.

Aspirin is a kind of nonsteroidal anti-inflammatory drugs. It is the first hint of aspirin's potential role in tumor prevention and treatment when Gasic found that tumor metastasis is reduced in thrombocytopenia mice, and then the research confirmed that aspirin treatment can significantly reduce the tumor metastasis. In recent years, a lot of epidemiological evidence and clinical trials found that aspirin played an important role in cancer prevention, at the same time, more experimental study has found that it can also play a role in tumor treatment. Our previous animal experiments found that a combination of sorafenib and aspirin can reverse the negative effect of sorafenib which promoted tumor metastasis, and obviously prolong survival of a tumor-burdened nude mice.

So, the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Control Trial of the Effect of Sorafenib Combined With Aspirin in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma
Study Start Date : April 2016
Actual Primary Completion Date : February 11, 2019
Actual Study Completion Date : February 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: control
just follow up after liver resection in HCC patients
Other: control
just follow up

Active Comparator: sorafenib
use sorafenib after liver resection in HCC patients
Drug: sorafenib
sorafenib 400mg bid po
Other Name: sorafenib treatment

Active Comparator: sorafenib and aspirin
use sorafenib and aspirin after liver resection in HCC patients
Drug: sorafenib
sorafenib 400mg bid po
Other Name: sorafenib treatment

Drug: aspirin
aspirin 100mg qd po
Other Name: aspirin treatment




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
  2. Number of patients with treatment-related bleedings who use aspirin [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The characteristics of the treatment history:

    1. No sorafenib treatment history, no sorafenib allergies.
    2. No chemotherapy, radiotherapy and transcatheter arterial chemoembolization(TACE) treatment history before surgery.
  • The characteristics of the tumor:

    1. The pathological results is hepatocellular carcinoma.
    2. Meet any of the following articles:

      • Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number>3,Tumor size>8cm,Tumor margin is not clear and no complete capsule.
      • With the embolus in Portal vein, hepatic vein or bile duct.
      • Preoperative rupture or invasion the adjacent organs.
      • The positive cut edge.
      • Residual lesions showed by Postoperative digital subtraction angiography(DSA).
      • Alpha fetoprotein(AFP) did not drop to normal range two months after surgery.
  • The characteristics of the patients:

    1. The patient age was between 18-75.
    2. The American Society of Anesthesiologists(ASA)score was I-III.
    3. No history of esophageal varices and gastrointestinal bleeding.
    4. The Child-pugh score was A.
    5. Routine blood test: the leukocyte>2.5*10^9, platelet> 60*10^9.
    6. The Prothrombin time was prolonged less than 2 second.
    7. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points

Exclusion Criteria:

  • Sorafenib treatment before surgery.
  • Pregnant or lactating women.
  • The Child-pugh score was B-C.
  • Patients with other malignant tumor.
  • Patients with mental illness.
  • Patients participated in other clinical trials in last three months.

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 ClinicalTrials.gov identifier (NCT number): NCT02748304


Locations
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China
Huashan hospital
Shanghai, China, 200040
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Lunxiu Qin, MD Department of general surgery, Huashan hospital, Fudan University

Publications of Results:

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Responsible Party: Lunxiu Qin, Director of the general surgery department, Huashan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT02748304     History of Changes
Other Study ID Numbers: Huashan 003
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Aspirin
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Sorafenib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors