Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Sponsor
Taizhou Hanzhong biomedical co. LTD
Study ID
NCT04741165
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HX008 — DRUG
    200 mg administered as IV infusion on Day 1 of each 21-day cycle.
  • Bevacizumab — DRUG
    15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
  • Lenvatinib — DRUG
    Administered orally once a day during each 21-day cycle

Study Details

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody HX008 plus bevacizumab or lenvatinib in the first-line treatment of patients with unresectable hepatocellular carcinoma.

Key Dates

First listed
Feb 5, 2021
Start date
Jan 7, 2021
Status verified
Feb 2021
Primary completion
Apr 30, 2022
Completion
Oct 30, 2022

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: HX008+Bevacizumab
    Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.
  • Experimental: Experimental: HX008+Lenvatinib
    Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 15 months ]

Central Contacts

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