Active — Not RecruitingPhase 2

Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection

Taiwan30 participantsStarted 2020-11-02

Plain-language summary

PD1 blockade has been approved as salvage therapy for advanced hepatocellular carcinoma (HCC). Although there is not solid evidence that PD1 blockade would induce hepatitis B virus (HBV) reactivation, previous clinical trials of PD1 blockade required enrolled patients to receive anti-HBV medications and control the viral load to be under 100-2000 IU/mL before initiation of PD1 blockade therapy. Such a requirement may not be necessary and could delay the treatment. Guidelines for prevention of chemotherapy induced HBV reactivation only suggest combining anti-HBV medications during the chemotherapy course without such a requirement of very load HBV viral load. The investigators hypothesized that under anti-HBV medications, patients with advanced HCC and active chronic hepatitis B virus (HBV) infection can receive durvalumab treatment without increased risks of HBV reactivation and related complications.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Haemoglobin ≥9.0 g/dL
✓. Absolute neutrophil count (ANC) ≥1.0 x 109/L (\> 1,000 per mm3)
✓. Platelet count ≥75 x 109/L (\>75,000 per mm3)
✓. Serum bilirubin ≤2 x institutional upper limit of normal (ULN).
✓. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless active liver malignancies are present, in which case it must be ≤5x ULN
✓. Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance

Exclusion criteria

✕. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
✕. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
✕. Adequately treated carcinoma in situ without evidence of disease

What they're measuring

The rate of HBV reactivation during durvalumab treatment

Timeframe: 30 months

Trial details

NCT IDNCT04294498

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

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