RecruitingPhase 2NCT07324824

Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma

Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study


Sponsor

Sun Yat-sen University

Enrollment

37 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — sintilimab (an immunotherapy) and a biosimilar version of bevacizumab (a drug that cuts off blood supply to tumors) — given before surgery in people with liver cancer (hepatocellular carcinoma, or HCC) that has not yet spread but is larger than what standard transplant guidelines typically allow. The goal is to shrink the tumor enough to make surgery safer and more successful. **You may be eligible if...** - You are 18 or older - You have liver cancer confirmed by imaging or pathology, and it is considered resectable (can be surgically removed) - You have not received any prior treatment for liver cancer - Your liver function is well-preserved (Child-Pugh class A) - Your expected survival is greater than 6 months and you are in generally good health **You may NOT be eligible if...** - You have a rare liver cancer type (cholangiocarcinoma, fibrolamellar, or sarcomatoid) - You have had a liver transplant or a history of hepatic encephalopathy (brain fogging from liver failure) - You have had recent serious bleeding from esophageal or gastric varices (enlarged veins) - You have uncontrolled high blood pressure or blood clotting problems - You had a major blood vessel event (heart attack, stroke, pulmonary embolism) in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsintilimab combined with bevacizumab biosimilar

Drug: Sintilimab: 200mg IV Q3W D1 (3 cycles) Drug: Bevacizumab Biosimilar: 15mg/kg, IV, Q3W, D1 (2 cycles)


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07324824


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