Lenvatinib

13

Review clinical trials related to Lenvatinib. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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 high-mortality global malignancy with a heavy disease burden in China. Although curative surgical resection improves survival for early-stage HCC patients, the 5-year postoperative recurrence rate remains as high as 50%-70%. Postoperative adjuvant TACE and systemic TKIs are standard treatments for high-risk HCC, yet both therapies have prominent drawbacks, including limited response rates, unavoidable toxicities, and inconsistent clinical benefits. Current treatment decisions rely on conventional clinical and pathological features without precise biomarkers, leading to inadequate individualized therapy and wasted medical resources. Tumor immune microenvironment and multimodal imaging-pathological features critically determine HCC treatment sensitivity. Artificial intelligence and deep learning based on preoperative radiomics and postoperative H\&E whole-slide imaging (WSI) can capture hidden tumor biological characteristics and predict therapeutic responses. However, no validated multimodal AI model is available for predicting postoperative TACE and TKI treatment outcomes in HCC, lacking large-scale multicenter prospective evidence. This study aims to construct and validate a multimodal deep learning model integrating preoperative contrast-enhanced CT/MRI, postoperative WSI, pathological reports, and clinical data, to precisely identify HCC patients sensitive to postoperative adjuvant TACE or TKI therapy and optimize individualized treatment strategies. This is a hybrid retrospective-training and prospective observational multicenter study with no clinical intervention. A total of 10,000 retrospective HCC surgical patients will be enrolled to develop an AI classification model for predicting responses to four postoperative treatment strategies: surgery alone, surgery plus TACE, surgery plus TACE combined with systemic therapy, and surgery plus exclusive systemic therapy. Subsequently, 1,000 eligible postoperative HCC patients will be prospectively and consecutively enrolled from 10-15 centers. The AI model will generate adjuvant therapy predictions without interfering with real clinical decisions. Patients will be divided into prediction-consistent and prediction-inconsistent cohorts based on the match between model predictions and actual treatments. Long-term follow-up will be performed to compare prognostic outcomes and validate the model's real-world performance and stability. Key inclusion criteria: histopathologically confirmed HCC; aged 18-75 years; received R0 curative resection; available qualified H\&E-stained FFPE slides for digital scanning; complete clinical, pathological and follow-up data; high-quality preoperative contrast-enhanced CT/MRI images eligible for AI analysis. Key exclusion criteria: prior preoperative anti-tumor therapy with unavailable baseline data; concurrent other primary malignancies; non-R0 resection; unqualified pathological slides or imaging data; severe missing clinical or follow-up information.

Participants needed: 11,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Jun 10, 2026Locations: 1
Eligibility criteria

Histopathologically confirmed hepatocellular carcinoma; [+5]

Significant missing clinical or follow-up data; [+3]

Status: Not yet recruiting

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

Participants needed: 24
Trial details
Phase: Phase 2Age: 19+Biological sex: AllType: InterventionalSponsor: Ju Hyun ShimUpdated: Apr 7, 2026Locations: 1
Eligibility criteria

Signed informed consent form. [+17]

Albumin-bilirubin (ALBI) grade 3. [+9]

Status: Not yet recruiting

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.

Participants needed: 65
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Peking Union Medical College HospitalUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Participants who voluntarily participate in this study, sign the written informe... [+9]

Histological or cytological diagnosis of combined hepatocellular-cholangiocarcin... [+9]

Status: Recruiting

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.

Participants needed: 32
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Aug 14, 2025Locations: 1
Eligibility criteria

diagnosis of primary HCC, confirmed histologically or clinically according to th... [+9]

recurrent HCC; [+6]

Status: Recruiting

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)

Participants needed: 35
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Zhejiang Cancer HospitalUpdated: Feb 11, 2025Locations: 1
Eligibility criteria

Aged 18-75 years old (inclusive); [+8]

Pathologically diagnosed as non-hepatocellular carcinoma; [+14]

Status: Recruiting

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.

Participants needed: 300
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: Sun Yat-sen UniversityUpdated: Feb 6, 2025Locations: 1
Eligibility criteria

primary infiltrative HCC according to MRI or CT imaging characteristics. [+5]

HCC with tumor capsule. [+5]

Status: Recruiting

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.

Participants needed: 116
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Dec 3, 2024Locations: 1
Eligibility criteria

18-75 years; [+7]

under 18 years or over 75 years of age; [+2]

Status: Recruiting

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.

Participants needed: 84
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: First Hospital of China Medical UniversityUpdated: Oct 8, 2024Locations: 1
Eligibility criteria

Has a diagnosis of HCC confirmed by radiology, histology, or cytology; [+7]

The interval between the failure of systemic therapy and the beginning of combin... [+2]

Status: Recruiting

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.

Participants needed: 40
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Sep 23, 2024Locations: 1
Eligibility criteria

Clinical diagnosis of HCC. [+8]

Diffuse HCC; [+10]

Status: Recruiting

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.

Participants needed: 60
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Aug 13, 2024Locations: 1
Eligibility criteria

diagnosis of primary HCC, confirmed histologically or clinically according to th... [+9]

recurrent HCC; [+6]

Status: Recruiting

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.

Participants needed: 30
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Aug 9, 2024Locations: 1
Eligibility criteria

Diagnosis of infiltrative HCC. [+9]

HCC with capsule; [+10]

Status: Recruiting

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

Participants needed: 274
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Nov 7, 2023Locations: 1
Eligibility criteria

Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma... [+7]

disagreeing to receive follow-up observation and participate the clinical study; [+7]

Status: Not yet recruiting

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.

Participants needed: 27
Trial details
Phase: Phase 1, Phase 2Age: 20+Biological sex: AllType: InterventionalSponsor: National Taiwan University HospitalUpdated: Mar 2, 2023Locations: 1
Eligibility criteria

Male/female participants who are at least 20 years of age on the day of signing... [+9]

A WOCBP who has a positive urine pregnancy test within 72 hours prior to [alloca... [+31]