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

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444088
• Other study ID #: SHR-8068-II-201-HCC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 2, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Xin Shi
• Phone: 0518-82342973
• Email: xin.shi.xs3[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Adebrelimab
intravenous infusion
• Bevacizumab
intravenous infusion
• SHR-8068
intravenous infusion

Locations

Country	Name	City	State
China	Anhui Provincial Hospital Ethics Commitee	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity		The observation period is 21 days after the first dose
Primary	Incidence and severity of grade =3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination		The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
Primary	Objective Response Rate	determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points	At the time point of every 6 or 9 weeks, up to 2 years
Secondary	Disease Control Rate, determined using RECIST v1.1 criteria		At the time point of every 6 or 9 weeks, up to 2 years
Secondary	Progression-Free-Survival assessed by investigator		up to 2 years]