ArticleJournal of hepatocellular carcinoma2026
Adjuvant Sintilimab Plus Bevacizumab After Curative Resection of Spontaneously Ruptured Hepatocellular Carcinoma: Protocol for a Prospective, Exploratory, Single-Arm Study (CLEAR-2).
Article in Journal of hepatocellular carcinoma, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07331883 (Sintilimab Combined With Bevacizumab Biosimilar as Adjuvant Treatment After Resection of Ruptured Hepatocellular Carcinoma), which is not on this map. Not yet cited in PubMed.
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Sintilimab Combined With Bevacizumab Biosimilar as Adjuvant Treatment After Resection of Ruptured Hepatocellular Carcinoma: A Prospective, Exploratory, Single-Arm Study (CLEAR-2)
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4 authors.
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Abstract
Background: Spontaneous rupture of hepatocellular carcinoma (srHCC) is a life-threatening complication associated with high perioperative mortality and increased postoperative recurrence, particularly peritoneal dissemination. Although timely haemostasis and curative-intent resection allow selected patients to achieve meaningful survival, postoperative management remains poorly defined, and patients with srHCC are usually excluded from major adjuvant trials. Methods: CLEAR-2 is a prospective, exploratory, multicentre, single-arm study evaluating adjuvant sintilimab plus bevacizumab biosimilar after R0 resection of srHCC. Thirty-five patients with imaging- or intraoperatively confirmed spontaneous rupture, China Liver Cancer (CNLC) stage I-II disease, complete radiological response 4-8 weeks after surgery, ECOG performance status 0-1, Child-Pugh class A liver function, and adequate organ function will be enrolled. Preoperative transarterial embolisation for haemostasis is permitted as a single bridging procedure without chemotherapeutic agents, followed by surgery within 2 weeks. Treatment consists of sintilimab 200 mg plus bevacizumab biosimilar 15 mg/kg intravenously every 3 weeks for up to 1 year or until recurrence, unacceptable toxicity, or withdrawal. The primary endpoint is disease-free survival. Secondary endpoints include overall survival, safety, and recurrence patterns. Tumour assessments will be performed every 12 weeks using contrast-enhanced CT or MRI according to RECIST version 1.1. Conclusion: CLEAR-2 is designed to generate preliminary prospective evidence on the feasibility, safety, and antitumour activity of adjuvant sintilimab plus bevacizumab in a highly selected, high-risk srHCC population. The findings may inform future randomized or comparative studies of postoperative strategies for srHCC. Trial Registration: NCT07331883.
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