Clinical Research Directory

Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning

Hepatocellular Carcinoma (HCC) is a common global malignancy, ranking 6th in incidence and 3rd in mortality, causing \~480,000 annual deaths. China accounts for over 45% of global cases, bearing a heavy disease burden. Radical resection is key for long-term survival in early-stage patients, but the 5-year postoperative recurrence rate reaches 50%-70%, limiting prognosis . Postoperative adjuvant therapies like Transarterial Chemoembolization (TACE) and Tyrosine Kinase Inhibitors (TKIs, e.g., sorafenib, lenvatinib) are widely used for high-risk recurrence patients TACE is suitable for intermediate-stage HCC by embolizing tumor vessels and perfusing chemo drugs ; multitarget TKIs inhibit pathways like VEGFR/PDGFR for anti-angiogenesis and anti-proliferation, serving as standard advanced HCC treatment . However, TACE has only 50%-60% objective response rate, with some patients suffering liver damage ; TKIs extend Recurrence-Free Survival (RFS) by 3-5 months in high-risk patients but have \<20% response rate in unselected populations, and \>50% incidence of grade 3-4 adverse events (hypertension, hand-foot skin reaction, proteinuria), leading to 20% treatment discontinuation. Currently, no efficient biomarkers exist for identifying beneficiaries, so treatment decisions rely on clinical experience (tumor size, vascular invasion), resulting in poor individualization, medical resource waste, and extra patient burden. Recent studies show the Tumor Immune Microenvironment (TIME) affects TACE/TKI sensitivity . TIME features (immune cell infiltration like CD8⁺ T cells, PD-L1 expression, spatial structure) correlate with treatment response. For example, immune-inflammatory TIME (high CD8⁺ T cell density) may improve response, while immune-exempt/desert phenotypes indicate resistance . However, TIME assessment relies on high-cost, complex technologies (mIHC, spatial transcriptomics) with poor standardization, limiting clinical use. AI (especially deep learning) enables mining deep pathological info from routine HE-stained Whole Slide Imaging (WSI, generated postoperatively for all HCC patients without extra sampling). WSI's cellular/tissue details map TIME features-models like CNN/ViT can predict "HE morphology → immune status" . HE-WSI deep learning models have high accuracy in predicting MSI (AUC 0.88) in colorectal cancer 18, PD-L1 (AUC 0.80) and TMB (AUC 0.91) in non-small cell lung cancer , and HCC recurrence risk (AUC 0.82)/immune infiltration (AUC 0.78) . Yet no studies focus on "postoperative adjuvant therapy efficacy prediction" with multicenter validation. Thus, building an HCC postoperative adjuvant therapy prediction model via HE-WSI and deep learning can clarify TIME's role and overcome tech limitations. This project integrates multicenter clinicopathological data and AI to establish/validate TACE/TKI efficacy prediction models, providing a reliable tool for HCC postoperative treatment decisions.

H101 Plus TACE for r/m HNSCC

This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r/m HNSCC patients.

DEB-TACE vs cTACE in HCC After TIPS

This is a Phase 3, open-label, multicenter, randomized controlled clinical trial designed to evaluate the efficacy and safety of Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) compared with Conventional Transarterial Chemoembolization (cTACE) in patients with hepatocellular carcinoma (HCC) that is beyond the Milan criteria and who have previously undergone a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The TIPS procedure is commonly performed to manage complications of portal hypertension, such as variceal bleeding or refractory ascites, in patients with cirrhosis. However, after TIPS, treatment options for HCC-particularly in cases exceeding the Milan criteria-remain limited and not well-defined in current guidelines. While TACE is a standard locoregional therapy for intermediate-stage HCC, its application in patients with a prior TIPS is controversial due to altered hepatic hemodynamics, which may increase the risk of liver toxicity and compromise treatment safety and efficacy. Preliminary retrospective data suggest that DEB-TACE, which uses calibrated drug-eluting microspheres, may offer a safer and more effective alternative to cTACE in this specific patient population by providing more controlled drug delivery and potentially reducing systemic and hepatic toxicity. The primary objective of this study is to determine whether DEB-TACE improves Overall Survival (OS) compared to cTACE in patients with beyond-Milan HCC after TIPS. Secondary objectives include comparing the safety profile, Progression-Free Survival (PFS), Objective Response Rate (ORR), Disease Control Rate (DCR), and Quality of Life (QoL) between the two treatment arms. The study aims to enroll 206 participants who will be randomly assigned in a 1:1 ratio to receive either DEB-TACE or cTACE. The trial will include a 24-month recruitment period and a 24-month treatment and follow-up phase, with a total study duration of 48 months. By directly comparing these two TACE approaches in a prospectively defined and randomized setting, this study seeks to provide high-level evidence to guide the optimal locoregional treatment strategy for HCC patients with a history of TIPS placement.

Sequential TACE-SBRT Combined With Targeted Immunotherapy for Patients With Intermediate to Advanced Liver Cancer

The goal of this clinical trial is to evaluate whether sequential transarterial chemoembolization (TACE) followed by stereotactic body radiotherapy (SBRT) combined with targeted immunotherapy is effective and safe for patients with intermediate to advanced hepatocellular carcinoma (HCC) who are not eligible for curative treatment such as surgery or liver transplantation. This is a single-center, single-arm, retrospective study. All participants included in the analysis will have received the combined treatment regimen. The main question the study aims to answer is: Can sequential TACE-SBRT combined with targeted immunotherapy improve the objective response rate (ORR) in patients with intermediate to advanced HCC? Interventions Participants in this study have undergone the following treatments: TACE: a minimally invasive procedure to block the blood supply to the tumor while delivering chemotherapy directly. SBRT: a highly precise form of radiation therapy targeting the liver tumor. Targeted immunotherapy: systemic treatment that stimulates the immune system to recognize and attack cancer cells. Participant Population The study includes adult patients diagnosed with intermediate to advanced HCC who were not candidates for curative resection or transplantation.

Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

This study is an open-label, randomized controlled, multicenter, phase III clinical trial

A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)

This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.

Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors

This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)

Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (CHANCE 2407)

Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.

Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma

To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma