HepatoCellular Carcinoma Clinical Trial
The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | August 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - older than 18 years old; - ECOG PS<3; - proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; - meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone - not previous treated for tumor; - Child-Pugh A or B; - at least one measurable lesion according mRECIST; - cannot afford sorafenib; - the lab test could meet: neutrophil count=1.5×109/L; hemoglobin=80g/L; platelet count=60×109/L; serum albumin=28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT=upper limit of normal plus 6 seconds; INR=2.3 - sign up consent; - unrolled by other clinical trials about hepatocellular carcinoma. Exclusion Criteria: - cannot tolerate TACE; - CNS or bone metastasis exits; - known history of other malignancy; - be allergic to related drugs; - underwent organ transplantation before; - be treated before (interferon included); - known history of HIV infection; - known history of drug or alcohol abuse; - have GI hemorrage or cardiac/brain vascular events within 30 days; - pregnancy; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Cancer Center of Sun Yat-Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate (RR) | 1 month after TACE | No | |
Primary | proportions of participants with severe adverse events according to CTCAE v4.03 | 1 month after TACE | Yes | |
Secondary | overall survival (OS) | From date of randomization until the date of death from any cause, assessed up to 60 months | No | |
Secondary | progression-free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | No | |
Secondary | time to progression (TTP) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | No |
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