Clinical Research Directory

Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial

The purpose of this clinical trial is to evaluate the efficacy and safety of regorafenib as a subsequent therapy for patients with hepatocellular carcinoma (HCC) who have failed prior lenvatinib treatment. This investigational study aims to assess the therapeutic benefits and safety profile of regorafenib in patients whose disease has progressed following the use of lenvatinib, a targeted therapy for hepatocellular carcinoma

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.

The Study Collect Clinical Data From the Treatment of Liver Cancer With New Drugs After 2019 and Integrate Biochemical and Pathological Indicators to Analyze Prognostic Outcomes, Including Overall Survival, Progression-free Survival, and Complications.

Hepatocellular carcinoma (HCC) is one of the most significant cancers in our country. Since 2019, many first-line and second-line therapeutic agents for HCC have been introduced. This study aims to evaluate the treatment outcomes of HCC patients in our hospital from 2019 to 2024 who received therapies other than the traditional sorafenib (Nexavar). The included drugs are Pembrolizumab, Atezolizumab (Tecentriq), Nivolumab, Lenvatinib, and Regorafenib (Stivarga). The study will collect clinical data from treated-cases with these novel agents after 2019 and integrate biochemical and pathological indicators to analyze prognostic outcomes, including overall survival, progression-free survival, and complications.

Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

This trial is a single-arm exploratory phase II clinical study initiated by the investigator. Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.

Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

A randomized controlled, multicenter, open, seamless phase II-III clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors which has extremely low postoperative recurrence-free survival. In this study, we aim to compare the prognosis in intrahepatic cholangiocarcinoma between Toripalimab combined with leventinib and GEMOX neoadjuvant treatment and the current clinical surgical treatment (traditional group).

TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.

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)

HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma

Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.

The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma

Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.

bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma

Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.

bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC

Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.

HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.