Treatment for advanced liver cancer using a combination of three drugs

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

This study is testing a new combination of three drugs to see if it can help people with advanced liver cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy, Adebrelimab, Bevacizumab
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT05444088 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of SHR-8068 when combined with Adebrelimab and Bevacizumab in patients with advanced hepatocellular carcinoma (HCC). It aims to assess the efficacy of this combination therapy in individuals who have either failed standard treatments or are not candidates for them. The study includes patients aged 18 to 75 with specific criteria related to their cancer stage and overall health. Participants will be monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced hepatocellular carcinoma who have failed standard treatment or have not received prior immunotherapy.

Not a fit: Patients with fibrolamellar hepatocellular carcinoma, autoimmune disorders, or those who have received immunosuppressive treatments recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who have limited treatment choices.

How similar studies have performed: While this approach is being evaluated in this trial, similar combinations have shown promise in other studies, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui

• Anhui Provincial Hospital Ethics Commitee — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Xin Shi

Conditions Advanced Hepatocellular Carcinoma