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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2022-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AK105 and anlotinib

Group Type EXPERIMENTAL

AK105

Intervention Type BIOLOGICAL

Anti-PD-1 antibody; IV infusion, 200 mg Q3W

Anlotinib Hydrochloride

Intervention Type DRUG

multi-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off

Interventions

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AK105

Anti-PD-1 antibody; IV infusion, 200 mg Q3W

Intervention Type BIOLOGICAL

Anlotinib Hydrochloride

multi-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No