The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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;