Safety and efficacy of transcatheter chemoembolization combined with hepatic arterial infusion chemotherapy for unresectable primary liver cancer: a single-center prospective study

Introduction

Background

Primary liver cancer (PLC) includes hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and combined hepatocellular-cholangiocarcinoma (cHCC-CCA). HCC is the most common subtype, accounting for approximately 75–85% of cases (1-3). According to statistics from the Global Cancer Observatory, liver cancer ranks sixth in global incidence and third in cancer-related mortality. In 2021, an estimated 739,299 new cases of liver cancer [95% confidence interval (CI): 673,114–821,948] were reported worldwide. In China alone, there were approximately 367,700 new cases in 2022 (4,5). Epidemiologic studies show that chronic liver disease, cirrhosis, hepatitis B virus (HBV) and hepatitis C virus (HCV) infections significantly increase PLC risk (6).

The 2024 Chinese Guidelines for diagnosis and treatment of PLC document that surgical resection is the primary choice of treatment for China Liver Cancer stage (CNLC) Ia–IIa PLC, with a 5-year overall survival (OS) rate of 74.6% (3,7-9). However, eligibility for surgery depends on factors including liver function, stage, and location (3). In clinical practice, many patients are diagnosed at intermediate or advanced stages. Therefore, they are ineligible for curative resection (3). For patients with unresectable PLC, both the 2024 European Association for the Study of the Liver (EASL) guidelines and the 2024 Chinese guidelines recommend transcatheter arterial chemoembolization (TACE) as a first-line treatment option (3,10). TACE involves the injection of chemotherapeutic agents (e.g., epirubicin or platinum-based drugs) mixed in lipiodol into tumor-feeding arteries, inducing tumor necrosis (11). However, the efficacy is limited in patients with a large tumor burden (12). Hepatic arterial infusion chemotherapy (HAIC) is another locoregional treatment. It has widespread use in Asia, particularly in China (13-17). Unlike TACE, HAIC does not involve embolization process, it delivers a continuous infusion of high-concentration chemotherapy drugs directly into the tumor via the catheter. This method increases local drug concentration while minimizing systemic toxicity (11). In China, the modified FOLFOX (m-FOLFOX) regimen (oxaliplatin, calcium folinate, and 5-fluorouracil) is most used (18).

Rationale and knowledge gap

Both TACE and HAIC are crucial interventional treatment strategies for unresectable PLC. They offer the potential to achieve tumor downstaging, facilitate conversion to surgical resection, and improve prognosis (3). Recently, the combination of TACE and HAIC has emerged as a promising approach, combining the embolic effect of TACE and the enhanced local chemotherapy of HAIC to improve outcomes in patients with large tumors (3,11). Preliminary clinical studies suggested that TACE combined with HAIC significantly prolong progression-free survival (PFS) and OS compared to a single treatment modality in patients with a large tumor burden or portal vein tumor thrombus (19,20). However, there is a lack of high-quality evidence supporting the TACE + HAIC treatment for unresectable PLC, and the precise role of this combination in facilitating translational therapy is yet to be clearly established (21).

Objective

Therefore, this single-center prospective study aims to evaluate the safety and preliminary efficacy of TACE + HAIC in patients with unresectable HCC and characterized by tumors larger than 5 cm in diameter. The findings are expected to contribute to clinical decision-making and offer insights into optimizing interventional strategies and advancing potential downstaging approaches. We present this article in accordance with the STROBE reporting checklist (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-459/rc).

Methods

Study design and participants

This prospective, single-center, single-arm study enrolled patients with unresectable HCC to receive TACE + HAIC between February 2023 and September 2024 at the Department of Interventional Treatment, Beijing No. 6 Hospital. Unresectability was determined by a multidisciplinary team (MDT), and all participants met strict eligibility criteria.

Inclusion criteria:

• Pathologically or clinically confirmed HCC according to the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition) (3);
• Eastern Cooperative Oncology Group performance status of 0 or 1, and Child-Pugh class A liver function;
• At least one target lesion ≥5 cm on imaging without distant metastasis;
• Deemed unresectable or unlikely to receive benefit from surgery by MDT;
• Provided written informed consent and agreed to protocol follow-up.

Exclusion criteria:

• Severe systemic diseases (liver, kidney, heart, or lung dysfunction);
• Coagulation disorders (platelets counts <50×10⁹/L, International normalized ratio >1.5, or prothrombin time >18 seconds);
• Allergy to contrast agents;
• Active infections;
• Psychiatric conditions interfering with compliance;
• Other factors deemed unsuitable by investigators.

Treatment procedure

All procedures were performed by four experienced interventional radiologists following standardized protocols. Anesthesiologists and nursing staff supported procedural safety and monitoring. Each treatment cycle included one TACE session followed by one HAIC session, repeated every 3 weeks for up to four cycles. Treatment was discontinued upon disease progression [by modified Response Evaluation Criteria in Solid Tumors (mRECIST)], unacceptable toxicity, or MDT-assessed surgical eligibility. Detailed procedures are provided in Appendix 1.

Postoperative evaluation and follow-up

All patients underwent blood tests (including complete blood count, liver and renal function, and tumor markers) pre-treatment and within 1 week after each cycle. Abdominal contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) was performed every 3 months, with tumor response assessed using mRECIST. For potential surgical conversion, cases showing significant remission (e.g., partial response by mRECIST or ≥50% tumor volume reduction) and resectable lesions were reviewed by the MDT, including surgeons, interventional radiologists, oncologists, and imaging specialists. Surgical decisions considered MDT input, patient condition, liver function, and patient/family preferences. Follow-up was conducted via outpatient visits or phone calls, ending in May 2025.

Study endpoint

The primary endpoints were PFS, defined as the time from treatment initiation to disease progression or death due to any cause, and OS, defined as the time from treatment initiation to death due to any cause. Secondary endpoints included ORR and DCR, assessed by mRECIST. Safety was evaluated based on adverse events referenced from the LEAP-012 study (with modifications), using CTCAE v5.0 for grading (21,22).

Statistical analysis

Continuous variables are summarized as means ± standard deviations or medians with interquartile ranges (IQRs). Categorical variables are presented as counts and percentages. Analyses excluded missing data. PFS and OS were estimated using the Kaplan-Meier method. All data were analyzed using Stata 18.0 BE (StataCorp, College Station, TX, USA) (23).

Ethical consideration

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved ethically by the Ethics Committee of Beijing No. 6 Hospital (approval No. KJ 20241-1) and informed consent was obtained from all individual participants.

Results

Baseline characteristics

Table 1 presents baseline characteristics. The mean age was 59.38±9.37 years, and most patients were male (86.2%). Cirrhosis was present in 44.8% patients, with HBV and HCV infections in 89.7% and 6.9%, respectively. Multiple lesions were seen in 65.4% patients, mainly in the right lobe (48.3%), followed by bilobar (34.5%) and left lobe (17.2%) involvement. The median value of largest tumor diameter was 9.85 cm (range, 5–16 cm), and 47.8% patients had alpha-fetoprotein (AFP) ≥400 ng/mL. Prior to TACE + HAIC, 17.2% patients were treatment-naïve; others had received TACE, HAIC, ablation, targeted therapy, immunotherapy, or surgery.

Tumor response post-treatment

Table 2 summarizes tumor response. Of 29 patients, 22 were evaluable by mRECIST; 6 (27.3%) achieved complete response (CR), 11 (50.0%) partial response (PR), 3 (13.6%) stable disease (SD), and 2 (9.1%) progressive disease (PD). ORR and DCR were 77.3% and 90.9%, respectively. Three patients (10.3%) underwent successful radical hepatectomy after MDT evaluation, following an average of 3±1 TACE + HAIC cycles. The median time from treatment initiation to surgery was 7 months (IQR, 2–9 months). Post-treatment, 21 patients (72.4%) continued with targeted, or immunotherapy based on clinical guidance and personal preference, detailed regiments of targeted or immunotherapy treatments are listed in Table 3. Among the 21 patients who received systemic therapy following TACE + HAIC, the most common regimen was pembrolizumab + lenvatinib (33.3%), followed by lenvatinib monotherapy (19.1%) and camrelizumab with rivoceranib (14.3%). Atezolizumab + bevacizumab was used in 9.5% of patients. Other regimens, including tislelizumab + lenvatinib, sintilimab with tislelizumab, pembrolizumab with sorafenib, tislelizumab alone, and pembrolizumab alone, were each administered in a single patient (4.8%) for each.

Treatment-related adverse event (TRAE)

Twenty patients (68.97%) experienced at least one TRAE (Table 4). In total, 21 different types of TRAEs were reported. The most common were post-embolization syndrome and increased γ-glutamyl transferase, which occurred in 10 patients each (34.5%). Other frequent TRAEs included decreased platelet count (9 patients, 31.0%), decreased white blood cell count (7 patients, 24.1%), and weight loss (6 patients, 20.7%). TRAE with a prevalence between 10–20% included rash (5 patients, 17.2%), increased blood bilirubin and hypothyroidism (4 patients each, 13.8%), as well as decreased neutrophil count, diarrhea, hepatic pain, fatigue, and decreased lymphocyte count (3 patients each, 10.3%). Less common events included hypoalbuminemia, hypertension, decreased appetite bloating, immune-related pneumonitis, and dysphonia (2 patients each, 6.9%). Hyperthyroidism and increased blood alkaline phosphatase were reported in 1 patient each (3.4%). All adverse events were grade 1–2 and were effectively managed with supportive treatment. No grade ≥3 adverse events were observed.

Short-term survival outcomes

As of the follow-up end date (May 1, 2025), nine patients died. Kaplan-Meier curves (Figures 1,2) show that median PFS and OS were not reached due to the short follow-up (median 16 months) and small sample size. The 6-month survival rate was 90.0% (95% CI: 67.0–98.0%), and both 12- and 18-month survival rates were 85.0% (95% CI: 60.0–95.0%).

Figure 1 Kaplan-Meier curve for progression-free survival. The blue solid line represents the estimated progression-free survival, and the shaded grey area indicates the corresponding 95% confidence interval. The x-axis shows time to progression (months), and the y-axis represents the probability of survival without disease progression. CI, confidence interval.

Figure 2 Kaplan-Meier curve for overall survival. The blue solid line represents the estimated overall survival, while the grey shaded area indicates the corresponding 95% confidence interval. The x-axis denotes overall survival time (months), and the y-axis represents the probability of survival. CI, confidence interval.

Case presentation

We present a case of surgical conversion following TACE + HAIC. A 52-year-old man had an 8.4 cm × 8.4 cm right-lobe hepatic mass with increased fluorodeoxyglucose uptake [maximum standardized uptake value (SUVmax) 6.8] on positron emission tomography-computed tomography (Figure 3A). After arterial angiography, he received TACE followed by HAIC (Figure 3B,3C). After four treatment cycles, MRI showed significant tumor shrinkage and PR per mRECIST (Figure 3D,3E). Following MDT evaluation, the patient underwent radical hepatectomy. At 5 months post-surgery, contrast-enhanced CT showed no recurrence (Figure 3F,3G).

Figure 3 Imaging findings and combined treatment course of the patient with hepatocellular carcinoma. (A) The PET-CT indicated that the patient was found with a hepatic mass located in the right lobe and was 8.4 cm × 8.4 cm; (B,C) the process of TACE + HAIC procedure; (D,E) follow-up contrast-enhanced MRI after four cycles of TACE combined with HAIC treatment; (F,G) contrast-enhanced CT was performed five months after surgical resection for follow-up. CT, computed tomography; HAIC, hepatic arterial infusion chemotherapy; MRI, magnetic resonance imaging; PET, positron emission tomography; TACE, transcatheter arterial chemoembolization.

Discussion

PLC is characterized by high malignancy, rapid progression, and poor prognosis, with a 5-year OS rate of approximately 22% (24). Recently, the treatment strategy for unresectable PLC has evolved from monotherapy toward multidisciplinary approaches. TACE and HAIC have demonstrated clinical value and are widely used (3,10). For patients with unresectable PLC, the development of effective combination treatment strategies remains a crucial area of ongoing clinical research and practice.

The role of TACE as the first-line treatment for intermediate-stage PLC in improving the prognosis of unresectable cases is well established. A study by Li et al. reported that among patients with unresectable HCC who treated with TACE alone, the median PFS and OS were 9.2 and 13.5 months, respectively, the ORR and DCR were 16.7%, and 71.4%, respectively (25). Another study by Cai et al. evaluated the efficacy of drug-eluting bead TACE (D-TACE), showing 1-, 2-, and 3-year PFS rates of 68.8%, 40.6%, and 31.3%, respectively, and corresponding OS rates were 84.4%, 71.9%, and 53.1% (26). However, due to the possibility of vascular recanalization, recurrence remains a major concern of TACE (27). Wu et al. reported recurrence rates of 33.3% and 8.3% at 3 months for conventional TACE and D-TACE, respectively, and 6-month recurrence rates of 16.7% and 43.3% (28). Additionally, HAIC has gained increasing attention recently as a locoregional treatment for unresectable HCC. Li et al. reported that the FOLFOX regimen HAIC in patients with large HCC resulted in a median OS of 23.1 months and a median PFS of 9.6 months (12). In this study, we reported 29 patients with unresectable PLC treated with TACE + HAIC, which led to an ORR of 77.27% and a DCR of 86.6%. The 6-month survival rates were 90% and 85% for both 12- and 18-month. Although the median OS and PFS have not yet been reached due to the short follow-up period and limited sample size, the observed short-term survival outcomes and response rates are promising. Our findings align with previous studies. Kondo et al. demonstrated that the combination of D-TACE and HAIC significantly improved the ORR to 74.6% and achieved a median OS of 26 months in patients with intermediate to advanced-stage HCC (29). Additionally, a real-world study reported that the combination of TACE, HAIC, a programmed death-1 (PD-1) inhibitor, and a tyrosine kinase inhibitor (TKI) yielded promising outcomes in initially unresectable HCC patients, with an ORR of 67.7% and a DCR of 90.3% (30). Notably, three patients achieved significant tumor burden reduction and subsequently underwent successful surgical resection, highlighting the potential of this combination therapy as a downstaging strategy for initially unresectable PLC. However, it is important to note that, in this study 72.4% of patients received subsequent targeted therapy and/or immunotherapy following TACE + HAIC. This may introduce potential confounding effects on PFS and OS making it difficult to accurately evaluate the long-term efficacy attributable solely to TACE + HAIC treatment.

Compared to monotherapy with either TACE or HAIC, the safety profile of the combined approach has been a concern and a key focus. Our findings indicate that the combination therapy did not significantly increase the incidence of severe TRAEs. Most patients experienced only mild to moderate adverse events, including post-embolization syndrome (34.48%), increased γ-glutamyl transferase (34.48%), decreased platelet count (31.03%), and decreased white blood cell count (24.1%), all of which were manageable with supportive care. These results suggest that the combined regimen is generally well tolerated in patients with adequate liver function reserve. Our findings are consistent with previous studies, which have also reported good overall tolerability during TACE + HAIC treatment without severe TRAEs. For example, prior research showed that approximately 20% of patients experienced increased γ-glutamyl transferase, 29% had increased transaminases, 15% experienced decreased platelet count, and 18% had increased bilirubin levels post treatment (30).

This study has the following strengths. Firstly, it is a prospective study that provides a clinical evidence-based basis for TACE + HAIC in the treatment of unresectable PLC. The study focused on a patient population with high clinical difficulty (median tumor diameter of 9.85 cm, 82.76% of patients had received multiple therapies such as targeted therapy, immunotherapy, TACE, HAIC, ablation, and surgical resection), and validated the feasibility of the combination treatment protocol through a standardized procedure.

However, there are several limitations in this study. Firstly, despite being a prospective study, the sample size was relatively small, including only 29 patients, which may limit the statistical validity and robustness of the results and may lead to selection bias and information bias, which need to be verified by enlarging the sample size in the future. Secondly, the study was a single-center design, which is limited by the characteristics of the population in a specific region, and the generalizability of the results still needs to be further verified by multicenter international studies. Meanwhile, this prospective study is a single-arm design without a control group, which limits the accuracy of efficacy comparison. Finally, this single-arm prospective study is limited by the absence of randomization and the heterogeneity of follow-up systemic treatments, which may have introduced potential bias in interpreting treatment efficacy. Subsequent studies need to incorporate a control group or randomized design to further validate efficacy. In addition, the follow-up period of the study is still limited, which is mainly focused on short-term efficacy and safety, and needs to be further extended to assess the long-term survival benefit and recurrence rate.

Conclusions

In conclusion, TACE combined with HAIC shows promising short-term safety and efficacy in patients with unresectable PLC, offering improved local tumor control and potential for downstaging to surgery. Despite being a single-center study with a small sample size, these findings provide early clinical support for this approach in intermediate to advanced liver cancer. Larger multicenter trials with longer follow-up are needed to assess long-term outcomes. Future studies should also explore molecular subtyping, biomarkers, and combination of immunotherapy to enhance personalized treatment and prognosis.

Acknowledgments

We sincerely thank all the patients and their families for participating in this study and for their trust and cooperation throughout the treatment process. We also extend our deepest gratitude to the doctors and medical staffs from the Department of Interventional Treatment at Beijing No. 6 Hospital for their expertise, dedication, and invaluable contributions to patient care and data collection. Their support was essential to the successful completion of this research.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-459/rc

Data Sharing Statement: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-459/dss

Peer Review File: Available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-459/prf

Funding: This study was supported by the Beijing Dongcheng District Outstanding Talents Team Program 2024 (No. 2024-dchrcpyzz-6).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jgo.amegroups.com/article/view/10.21037/jgo-2025-459/coif). C.X. reports that this study was supported by the Beijing Dongcheng District Outstanding Talents Team Program 2024 (No. 2024-dchrcpyzz-6). The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved ethically by the Ethics Committee of Beijing No. 6 Hospital (approval No. KJ 20241-1) and informed consent was obtained from all individual participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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