NCT04172571
Completed
Phase 2
An Open-Label Multi-Center Phase Ib/II Study of the Combination of AK105 and Anlotinib Hydrochloride in the First-Line Treatment of Patients With Unresectable Hepatocellular Carcinoma
ConditionsHepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Akeso
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Overview
Brief Summary
This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed written informed consent form voluntarily.
- •Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
- •Expected life expectance ≥ 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 or
- •Confirmation either by histology unresectable hepatocellular carcinoma..
- •BCLC stage C, and non-resectable BCLC stage B .
- •No prior systemic therapy for HCC.
- •Child-Pugh class A and B (≤7 points).
- •At least one measurable lesion according to RECIST criteria.
- •Adequate hematologic and end-organ function.
Exclusion Criteria
- •Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
- •Active ongoing infection requiring therapy.
- •History of severe hypersensitivity reaction to another monoclonal antibody.
- •Received any live attenuated vaccine within the last 30 days.
- •Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
- •Pregnant, breast feeding, or planning to become pregnant.
- •Active or prior documented autoimmune or inflammatory disease with some exceptions.
- •Central nervous system metastases and/or carcinomatous meningitis.
- •Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication.
- •Co-infection of HBV and HCV.
Arms & Interventions
AK105 and anlotinib
Experimental
Intervention: AK105 (Biological)
AK105 and anlotinib
Experimental
Intervention: Anlotinib Hydrochloride (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: up to approximately 18 months
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Secondary Outcomes
- Duration of response (DoR)(up to approximately 18 months)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK105 through 90 days after last dose of AK105)
- Number of subjects experiencing adverse events (AEs)(From the time of informed consent through 90 days after last dose of AK105)
- Progression-free survival (PFS)(up to approximately 18 months)
- Disease control rate (DCR)(up to approximately 18 months)
- Overall survival (OS)(up to approximately 24 months)
- Observed concentrations of AK105(From first dose of AK105 through 90 days after last dose of AK105)
Investigators
Study Sites (1)
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