NCT05444088 Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
| NCT ID | NCT05444088 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Advanced Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 129 participants |
| Start Date | 2022-08-02 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 129 participants in total. It began in 2022-08-02 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05444088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05444088 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05444088 currently recruiting?
Yes, NCT05444088 is actively recruiting participants. Contact the research team at xin.shi.xs3@hengrui.com for enrollment information.
Where is the NCT05444088 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT05444088 clinical trial?
NCT05444088 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 129 participants.
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