On Saturday 19 October 2025, at the European Society for Medical Oncology (ESMO), held in Berlin, Germany, Hengrui presented results from the CARES-009 trial assessing the combination of AiRuiKa (camrelizumab), a PD-1 inhibitor, and AiTan (rivoceranib), a VEGFR-2 tyrosine kinase inhibitor, as a perioperative treatment in patients with resectable hepatocellular carcinoma (HCC).
HCC has a high recurrence rate after curative resection. According to the AASLD practice guidelines, more than half of patients relapse within two years after resection. No current standard adjuvant or perioperative systemic therapies exist in HCC. A previous trial of Tecentriq in combination with Avastin from Roche did not significantly improve recurrence-free survival.
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The camrelizumab and rivoceranib combination demonstrated synergistic efficacy in advanced HCC. In a Phase III trial for unresectable HCC, this combination (approved in China) improved overall survival (OS) to 22.1 months compared with 15.2 months with sorafenib (hazard ratio (HR) 0.62; 95% CI0.49-0.80). These results provided a strong rationale for bringing the immunotherapy/anti-angiogenic duo into earlier, curative settings.
The Phase III CARES-009 trial (NCT04521153) evaluated perioperative camrelizumab plus rivoceranib in Chinese patients with resectable HCC at intermediate-to-high risk of recurrence, aiming to reduce post-surgery relapse by eradicating micrometastases and suppressing angiogenesis. At ESMO 2025, investigators reported that the combination significantly improved event-free survival (EFS), meeting its primary endpoint versus surgery alone. At a median follow-up of 21.3 months, the combination (42.1 months HR 0.63; 95% CI0.44-0.90) achieved more than double the EFS period compared with surgery alone (19.4 months, HR 0.59; 95% CI0.41-0.85; p = 0.0040).
The discontinuation rate of the combination was 8%. Its major pathological response (MPR) rate was markedly higher with perioperative therapy (35.1%) versus surgery alone (7.5%; p < 0.001), including 3.4% (five of 148 patients) achieving complete pathological remission. Relatively low complete pathological remission may be due to a low cycle setting (two cycles) for the neoadjuvant treatment. OS data remains immature, with only 39 events observed at this interim analysis. 37.6% of patients receiving the combination experienced grade 3 and above treatment-related adverse events, with hypertension and hepatotoxicity the most common, suggesting limited safety concerns and feasibility in the perioperative setting.
In summary, the CARES-009 data highlighted at ESMO 2025 presents a landmark in perioperative HCC management. According to GlobalData’s epidemiology insights, China accounts for more than 50% of global HCC cases (188,580 cases in 2024 in urban China), underscoring its importance as a primary market for HCC therapies. From a commercial standpoint, the results strengthen Jiangsu Hengrui’s dominance in the Chinese HCC market, expanding the potential of both camrelizumab and rivoceranib beyond advanced disease. Rapid adoption is expected in China, where both agents are marketed, while global expansion will depend on ongoing US Food and Drugs Administration review and harmonisation with Western regulatory standards. Despite receiving a second complete response letter for advanced HCC treatment in March 2025, these efficacy results could revitalise the confidence of the western market in Hengrui’s immuno-oncology pipeline.
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By GlobalDataIf the perioperative indication secures regulatory traction, it could differentiate the camrelizumab plus rivoceranib regimen from other PD-1/VEGF combinations which remain limited to advanced settings. Confirmed with mature OS data later, CARES-009 could establish perioperative PD-1 + VEGFR inhibition as a new global standard of care, reshaping the HCC treatment paradigm and expanding the immuno-oncology footprint in early-stage disease.
