Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

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

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2026-06-30

Brief Summary

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To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.

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Detailed Description

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Conditions

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Advanced Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The phase Ib design is for dose finding and dose confirmation, using modified 3+3 design; the phase II design is for efficacy expansion through randomization.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adebrelimab in combination with Bevacizumab

Group Type EXPERIMENTAL

Adebrelimab

Intervention Type DRUG

intravenous infusion

Bevacizumab

Intervention Type DRUG

intravenous infusion

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1

Group Type EXPERIMENTAL

Adebrelimab

Intervention Type DRUG

intravenous infusion

Bevacizumab

Intervention Type DRUG

intravenous infusion

SHR-8068

Intervention Type DRUG

intravenous infusion

Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2

Group Type EXPERIMENTAL

Adebrelimab

Intervention Type DRUG

intravenous infusion

Bevacizumab

Intervention Type DRUG

intravenous infusion

SHR-8068

Intervention Type DRUG

intravenous infusion

Interventions

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Adebrelimab

intravenous infusion

Intervention Type DRUG

Bevacizumab

intravenous infusion

Intervention Type DRUG

SHR-8068

intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18\~75 years old, both male and female;
2. Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
3. Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
4. At least one measurable lesion based on RECIST v1.1 criteria;
5. Barcelona clinic liver cancer: Stage B or C;
6. ECOG PS score: 0-1 points;
7. Child-Pugh score: ≤ 7;
8. Expected survival period ≥ 3 months;
9. Adequate organ function.

Exclusion Criteria

1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
2. Patients with any active, known or suspected autoimmune disorder;
3. Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
4. With known severe allergic reactions to any other monoclonal antibodies;
5. Patients with known CNS metastasis or hepatic encephalopathy;
6. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
7. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
8. Patients with other malignancies currently or within the past 5 years;
9. Patients with hypertension which cannot be well controlled by antihypertensives;
10. Uncontrolled cardiac diseases or symptoms;
11. Patients with other potential factors that may affect the study results.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No