Clinical Research Directory

Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma

The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.

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.

Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma

This is a phase 2, Simon's 2-stage designed study with 2 cohorts of anti-PD-1/PD-L1 experienced patients with untreated brain metastases: 1) melanoma and 2) renal cell carcinoma (RCC).

Radiomics Subtyping to Guide Surgery vs. Maintenance Therapy After HCC Downstaging

The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are: Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data? Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy? Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging? The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.

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

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.