The 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) was held in San Francisco, California, USA from January 23 to 25, local time. The "National Multicenter, Randomized, Parallel Control Study of Transarterial Chemoembolization (TACE) Combined with Carrelizumab and Apatinib for the Treatment of Unresectable Hepatocellular Carcinoma (HCC) (CARES-005)" led by Academician Gao-Jun Teng, Academician of the Chinese Academy of Sciences and President of Zhongda Hospital Affiliated to Southeast University, and jointly conducted by 22 centers across the country, was successfully selected for the Oral session of the 2025 ASCO GI.

Gao-Jun Teng at the 2025 ASCO GI Conference

CARES 005：Exploration of treatment options based on the current status of diagnosis and treatment of hepatocellular carcinoma in China

The tumor characteristics of hepatocellular carcinoma (HCC) patients in China differ significantly from those in North America and Japan. In China, HCC is often associated with hepatitis B virus (HBV) infection, with over 60% of patients diagnosed at BCLC B/C stages, presenting with larger tumor diameters, and more than one-fifth of the population also has portal vein tumor thrombus (PVTT) 2,3. Therefore, the treatment of HCC in China requires a more diverse range of approaches and multidisciplinary collaboration.

As a foundational treatment for intermediate and advanced HCC, transarterial chemoembolization (TACE) has shown good short-term efficacy, but its long-term outcomes still need further improvement. Given the high heterogeneity of HCC, relying solely on TACE is insufficient, and a considerable number of patients still require combination therapy to further enhance survival benefits. The advent of targeted and immunotherapy has enriched the treatment modalities for HCC, and the combination of TACE with systemic therapy offers more exploration potential and value in terms of patient selection, treatment regimens, and timing. In clinical practice, the CHANCE series of studies led by Academician Teng Gaojun have extensively explored patient populations and combination regimens 4,5, suggesting the potential benefits of combining TACE with targeted and immunotherapy, thereby contributing robust interventional academic insights to HCC treatment. The significance of the CARES-005 study lies in providing reference evidence for clinical practice in China from the perspective of randomized controlled trials (RCTs).

CARES-005 Research Design

According to the results of the phase 2 CARES-005 trial (NCT04559607) presented at ASCO GI 2025, the combination of transarterial chemoembolization (TACE) with camrelizumab/apatinib demonstrated a statistically significant improvement in progression-free survival (PFS) compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC).

PFS according to RECICL assessment (ITT population)

Based on the Response Evaluation Criteria in Cancer of the Liver (RECICL), the median PFS in the intent-to-treat (ITT) population was 10.8 months (95% CI, 8.8–13.7) for the TACE plus camrelizumab/apatinib group, compared to 3.2 months (95% CI, 2.4–4.2) for the TACE-alone group (HR, 0.34; 95% CI, 0.24–0.50; p < 0.0001). The 6-month PFS rates were 70.8% and 31.5% for the two treatment groups, respectively. Notably, PFS was superior in the TACE plus camrelizumab/apatinib group across all subgroups stratified by factors such as age, sex, ECOG performance status, and prior TACE exposure.

PFS according to RECICL in key subgroups

According to RECICL criteria, the overall response rate (ORR) was 65.0% (95% CI, 54.8%–74.3%) in the TACE plus camrelizumab/apatinib group and 29.0% (95% CI, 20.4%–38.9%) in the control group. The disease control rates (DCR) were 87.0% and 63.0%, respectively, while the median duration of response (DOR) was 11.4 months and 6.9 months, and the median time to untreatable progression (TTUP) was 13.7 months and 3.9 months, respectively.

When assessed using the modified RECIST (mRECIST) criteria, the ORR was 61.0% (95% CI, 50.7%–70.6%) in the TACE plus camrelizumab/apatinib group and 29.0% (95% CI, 20.4%–38.9%) in the control group. The DCR was 85.0% (95% CI, 76.5%–91.4%) and 58.0% (95% CI, 47.7%–67.8%), respectively, and the median DOR was 7.6 months and 4.7 months, respectively. 

Tumor response according to RECICL/mRECIST

The data showed that PFS improved in patients with Barcelona Clinic Liver Cancer (BCLC) stage A/B disease treated with TACE plus camrelizumab/apatinib, as assessed by both RECICL (HR, 0.34; 95% CI, 0.21–0.55) and mRECIST criteria (HR, 0.44; 95% CI, 0.28–0.70). Similar improvements were observed in BCLC stage C patients according to RECICL (HR, 0.39; 95% CI, 0.22–0.67) and mRECIST criteria (HR, 0.44; 95% CI, 0.25–0.77).

Additionally, the TACE plus camrelizumab/apatinib group demonstrated improvements in overall survival (OS) for both BCLC stage A/B (HR, 0.88; 95% CI, 0.48–1.61) and BCLC stage C patients (HR, 0.83; 95% CI, 0.48–1.53).

OS (ITT population)

TRAEs with an incidence of ≥10%

Professor Gao-Jun Teng, Academician of the Chinese Academy of Sciences and affiliated with Zhongda Hospital, Southeast University, stated in an oral presentation: "The CARES-005 study demonstrated that, compared to TACE alone, TACE combined with immunotherapy-based systemic therapy provides clinically and statistically significant progression-free survival (PFS) improvements for patients with unresectable hepatocellular carcinoma (HCC). Furthermore, the safety profile of TACE plus camrelizumab/apatinib combination therapy was manageable and consistent with the known adverse event (AE) characteristics of TACE, camrelizumab, and apatinib in unresectable HCC. Although overall survival (OS) data remain immature, a trend toward OS improvement was observed in the TACE combined with camrelizumab/apatinib group. The research team will continue follow-up assessments."

视频链接：https://www.onclive.com/view/dr-teng-on-the-phase-2-cares-005-study-of-tace-plus-camrelizumab-and-rivoceranib-in-unresectable-hcc