Efficacy and Safety of Tyrosine Kinase Inhibitors Combined with Sintilimab and Transarterial Chemoembolization in Barcelona Clinic Liver Cancer Stage B/C Hepatocellular Carcinoma - Pooled Analysis

Sep 30, 2026

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Pooled analysis evaluates the efficacy and safety of tyrosine kinase inhibitors combined with sintilimab and transarterial chemoembolization (TKIs-Sin-TACE) in patients with unresectable hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) stage B/C. Searches of PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov up to October 1, 2024 identified six studies with 336 patients. Outcomes include objective response rate, disease control rate, progression-free survival and overall survival, alongside treatment-related adverse events graded at least 3. Results show an overall favorable efficacy and manageable safety profile, supporting continued validation through large multicenter randomized trials.

LanguageEnglish

CategoryHealthcare

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Pages9

Reading Time23 min

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Background

Methods

Results

Conclusions

Key findings

What is known and what is new?

What is the implication, and what should change now?

Efficacy and safety of tyrosine kinase inhibitors combined with sintilimab and transarterial chemoembolization in patients with Barcelona Clinic Liver Cancer stage B/C hepatocellular carcinoma: a pooled analysis Gen-Lin Lu1^, Jin-Ming Tu2, Asadullah Hussainzai3, Fei Tong1, Renya Jiang4 1Department of General Surgery, Longyou County People’s Hospital, Quzhou, China; 2Department of Gastroenterology, Longyou County People’s Hospital, Quzhou, China; 3Department of General Surgery, Nangarhar University Teaching Hospital, Nangarhar, Afghanistan; 4Department of Hepatobiliary surgery, Quzhou People’s Hospital, Quzhou, China Contributions: (I) Conception and design: GL Lu; (II) Administrative support: R Jiang; (III) Provision of study materials or patients: JM Tu, AHussainzai, F Tong; (IV) Collection and assembly of data: GL Lu, JM Tu; (V) Data analysis and interpretation: GL Lu, JM Tu, A Husinzai, F Tong; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Gen-Lin Lu, MA. Director of Department of General Surgery, Longyou County People’s Hospital, No. 1, Youqin Road, Longyou County, Quzhou 324400, China. Email: [genlinlu230@ gmail.com](genlinlu230@ gmail.com). Background: Trials on tyrosine kinase inhibitors combined with sintilimab and transarterial chemoembolization (TKIs-Sin-TACE) for the treatment of unresectable hepatocellular carcinoma (HCC) are ongoing and show promising results. However, the number of participants recruited so far has been relatively limited. This pooled analysis aims to evaluate the efficacy and safety ofTKIs-Sin-TACE in patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C HCC. Methods: To obtain potentially eligible studies, databases such as PubMed, Embase, Cochrane Library, Web of Science, and [ClinicalTrials.gov](ClinicalTrials.gov) were searched up to October 1, 2024. The Methodological Index for Non-Randomized Studies (MINORS) was used to evaluate literature quality and the levels of bias. A random-effects model was utilized to calculate the pooled rate and confidence interval (CI) . Results: This study included six studies involving a total of 336 patients with HCC at BCLC stage B/C. Regarding efficacy, the pooled objective response rate, disease control rate, integrated rates for 10-month progression-free survival, 10-month overall survival (OS), 20-month OS were 39%(95% CI: 26–55%),74%(95% CI: 60–84%),41%(95% CI: 30–54%), and 73%(95% CI: 54–86%), 30%(95% CI: 16–49%), respectively. Regarding safety, the aggregated incidence of treatment-related adverse events ≥ grade 3 was 23%(95% CI: 12–42%) . Conclusions: TKIs-Sin-TACE exhibits an efficacious and safe profile for Chinese patients with BCLC stage B/C HCC. Large-scale, global multicenter randomized-controlled trials are needed to further validate these findings. Keywords: Hepatocellular carcinoma (HCC); sintilimab (Sin); transarterial chemoembolization (TACE); tyrosine kinase inhibitors (TKIs) Submitted Jun 03, 2025. Accepted for publication Sep 10, 2025. Published online Dec 26, 2025. doi: 10.21037/jgo-2025-431 View this article at: [https://dx.doi.org/10.21037/jgo-2025-431](https://dx.doi.org/10.21037/jgo-2025-431) ^ ORCID: 0009-0005-2055-7441. © AME Publishing Company. J Gastrointest Oncol 2025;16(6):2741-2749 | [https://dx.doi.org/10.21037/jgo-2025-431](https://dx.doi.org/10.21037/jgo-2025-431) 2742 Lu et al. TKIs-Sin-TACEs’ efficacy and safety for HCC patients Introduction As indicated by the Global Cancer Observatory (GLOBOCAN) 2020 data, liver cancer had 905,677 new cases and caused 830,180 deaths globally in 2020, posing a severe threat to global health (1) . Systemic therapies, such as immunotherapy, molecular-targeted therapy, chemotherapy, and transarterial chemoembolization (TACE), are appropriate for patients with unresectable hepatocellular carcinoma (HCC), of which less than 15% of patients can survive 5-year (1) . Sintilimab

FAQs

What treatment regimen is assessed in this pooled analysis?

The analysis evaluates tyrosine kinase inhibitors combined with sintilimab and transarterial chemoembolization (TKIs-Sin-TACE) for patients with BCLC stage B/C hepatocellular carcinoma.

How many studies and patients were included?

Six studies involving a total of 336 patients with BCLC stage B/C HCC were included.

What efficacy outcomes were reported for BCLC stage B/C patients?

The pooled objective response rate was 39% and the disease control rate was 74%. Pooled survival estimates included 41% for 10-month progression-free survival and 73% for 10-month overall survival, with 30% for 20-month overall survival.

How was safety evaluated and what was the key adverse event result?

Safety focused on treatment-related adverse events, especially events of grade 3 or higher. The pooled incidence of treatment-related adverse events ≥ grade 3 was 23%, and commonly reported grade ≥ 3 events included hypertension and liver-function abnormalities.

Sep 30, 2026

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