Actively Recruiting
Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2026-01-16
37
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.
CONDITIONS
Official Title
Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and willing to sign an approved consent form
- Aged 65 18 years
- Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa)
- No prior anti-HCC treatment
- Child-Pugh class A
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Expected survival time of > 6 months
- Sufficient organ and bone marrow function
You will not qualify if you...
- Known cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar carcinoma
- History of organ transplantation or hepatic encephalopathy
- Pleural fluid, ascites, or pericardial effusion requiring drainage
- Recent esophageal or gastric variceal bleeding within 6 months or severe varices within 3 months
- Arterial or venous thromboembolic events within 6 months
- Life-threatening bleeding events within 3 months
- Severe bleeding tendency, coagulopathy, or ongoing thrombolytic therapy
- Chronic use of medications that inhibit platelet function (e.g., high-dose aspirin)
- Uncontrolled hypertension despite treatment or history of hypertensive crisis
- Symptomatic congestive heart failure or poorly controlled arrhythmias
- History of gastrointestinal perforation, intestinal obstruction, extensive bowel resection, or inflammatory bowel disease within 6 months
- Recent major surgery within 4 weeks or minor surgery within 7 days prior to enrollment
- Past or current severe pulmonary diseases
- Active acute or chronic hepatitis B or C infection above specified viral load thresholds
- Active tuberculosis or recent anti-TB treatment within 1 year
- HIV infection or known syphilis
- Severe active infection or poorly controlled infection
- Active autoimmune disease requiring systemic therapy within 2 years
- Use of immunosuppressive drugs within 4 weeks prior to enrollment (with exceptions)
- Recent live-attenuated vaccines within 4 weeks prior to enrollment or planned during study
- Use of immunomodulatory agents within 2 weeks prior to enrollment
- Uncontrolled metabolic disorders or other serious non-malignant diseases
- Diagnosis of other malignant tumors within 5 years prior to enrollment, with exceptions
- Prior receipt of anti-angiogenic agents or immunotherapies
- Known hypersensitivity to study drugs or excipients
- Participation in other clinical trials within 4 weeks prior to enrollment
- Pregnant or breastfeeding females
- Other acute or chronic diseases or psychiatric disorders that increase risk or interfere with study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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