A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05976568
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • QL1706 — DRUG
    7.5 mg/kg 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
  • Oxaliplatin injection — DRUG
    85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
  • Capecitabine — DRUG
    1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
  • Sintilimab — DRUG
    200 mg administered as IV infusion on Day 1 of each 21-day cycle

Study Details

The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.

Key Dates

First listed
Aug 4, 2023
Start date
Sep 1, 2023
Status verified
Jul 2023
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
668 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    QL1706 in combination with bevacizumab and chemotherapy
  • Experimental: Arm 2
    QL1706 in combination with bevacizumab
  • Experimental: Arm 3
    QL1706 in combination with chemotherapy
  • Active Comparator: Arm 4
    Sintilimab in combination with bevacizumab

Primary Outcome Measure

Objective Response Rate (ORR) (Phase II) [ Time Frame: Up to approximately 4 years ]

Central Contacts

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