A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: AK105; Drug: Anlotinib Hydrochloride

• Registration Number: NCT04172571
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-22
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 1.
• 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.
• For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.

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.
• Inadequately controlled arterial hypertension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK105 and anlotinib	Anlotinib Hydrochloride	-
AK105 and anlotinib	AK105	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	up to approximately 18 months	ORR is the proportion of subjects with CR or PR based on RECIST v1.1.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	up to approximately 18 months	DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Number of subjects who develop detectable anti-drug antibodies (ADAs)	From first dose of AK105 through 90 days after last dose of AK105	The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Number of subjects experiencing adverse events (AEs)	From the time of informed consent through 90 days after last dose of AK105	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Progression-free survival (PFS)	up to approximately 18 months	PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Disease control rate (DCR)	up to approximately 18 months	DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Overall survival (OS)	up to approximately 24 months	OS is the time from the date of first dosing to death due to any cause.
Observed concentrations of AK105	From first dose of AK105 through 90 days after last dose of AK105	The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China