Clinical Research Directory

Efficacy and Safety of SIRT-Y90 in Combination With Atezo + Bev for Unresectable Hepatocellular Carcinoma

This study adopted a bidirectional cohort study design. On the one hand, the previous clinical data, treatment exposure and clinical endpoint events of the enrolled patients were retrospectively collected. On the other hand, prospective regular follow-up was conducted from the date of enrollment to continuously observe long-term recurrence, progression and survival outcomes, and analyze the correlation between related factors and prognosis. The primary objective of this study was to describe the efficacy and safety of SIRT-Y90 in combination with atezolizumab and bevacizumab in adult patients with unresectable HCC in China. Medical records from approximately eight sites in China will be used.

Defining the Ablative Dose for Y-90 TARE

This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.

Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma and Lung Cancer

This is an investigator initiated trial to assess the efficacy and safety of a GPC3-targeting CAR-T therapy (REVO-UWD-03) in the HCC and Lung Cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.

Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma

Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates. This prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety

Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by by Percutaneous Ablation Procedure

This project is a Phase 2 trial testing the safety and efficacy of treatment with Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting in patients with BCLC A HCC treated by by percutaneous ablation (PA) procedure in a curative intent. DUMELEP is a Multicentre, Phase 2 trial Eligible patients will receive consecutively: 1. 1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting 2. percutaneous ablation procedure in a curative attempt at Day 30 3. 11 monthly Durvalumab 1500 mg infusions. 4. Classical follow-up during an additional year (every 3 months)

Prospective Evaluation of a Locked Risk-Stratified Surveillance Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma

This is a multicenter prospective observational cohort study in adults with hepatocellular carcinoma (HCC) without baseline extrahepatic metastasis who are receiving routine clinical management and follow-up at participating centers. The study evaluates the real-world implementation and clinical utility of a locked machine learning-guided risk stratification strategy for predicting lung and bone metastasis and supporting risk-stratified surveillance. The locked strategy uses prespecified 12-month risk thresholds and linked care pathways and is implemented without retraining or threshold revision. No study-mandated treatment or surveillance assignment is performed; clinical care remains at physician discretion according to local practice. The study assesses model transportability and calibration, implementation outcomes (including completion of prespecified actions, timeliness of action, and treatment activation), clinically actionable detection outcomes, patient-important outcomes, and longer-term survival. Comparative analyses use centre- and calendar-epoch-aligned usual-care episodes as the primary observational comparator.

Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin

Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

Intelligence System for Predicting Atezolizumab-Bevacizumab Response and Clinical Outcomes in Unresectable Hepatocellular Carcinoma

This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.

A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma

By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.

A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence

This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.

Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma

Radiotherapy is increasingly being used in the management of hepatocellular carcinoma (HCC) as a standalone treatment, or in combination with systemic therapy. Stereotactic Body Radiation Therapy (SBRT) causes cell death directly (via double-stranded breaks) and indirectly (via vascular bed damage or promotion of antitumour immunity). Unfortunately, the effect of cell death is not immediate and takes time. As a result, the typical arterial phase hyperenhancement on imaging may persist up to 12 months after radiotherapy, and it is not necessarily suggestive of presence of viable tumours. Therefore, there is no consensus on ideal timing of response assessment following radiotherapy to HCC. Therefore, a blood-based biomarker which can be done frequently and monitored dynamically, could be preferred for response assessment after radiotherapy. Circulating tumour DNA (ctDNA) is an emerging and promising biomarker in cancer management, which has been shown useful in cancer screening, guiding treatment, and informing prognosis. Currently, most of the clinical applications of ctDNA revolve around either the presence of ctDNA, or the genomic changes associated with these molecules. Biological properties of ctDNA such as fragment length, jaggedness of fragments, or epigenetic changes may provide additional information related to the tumour characteristics and its sensitivity to anti-cancer treatments. These biological properties of ctDNA are relatively unexplored in the context of radiotherapy. It is unknown whether these properties can be utilized for monitoring treatment response. We therefore propose to study the biological properties of ctDNA in relation to HCC patients undergoing radiotherapy.

Lenvatinib and Pembrolizumab With or Without BCAA in Unresectable HCC

The goal of this clinical trial is to learn whether adding branched-chain amino acids (BCAAs) to lenvatinib and pembrolizumab improves treatment outcomes in adults with unresectable hepatocellular carcinoma (HCC). The study will also evaluate the safety of this combination treatment. The main questions this study aims to answer are: Does the addition of BCAAs improve the time patients live without their cancer getting worse? Does the combination treatment improve tumor response compared with standard treatment alone? What medical problems or side effects do participants experience during treatment? Researchers will compare lenvatinib plus pembrolizumab with BCAAs to lenvatinib plus pembrolizumab alone to see whether adding BCAAs provides additional benefit for patients with unresectable HCC. Participants will: Be randomly assigned to receive lenvatinib and pembrolizumab with or without oral BCAAs Take lenvatinib by mouth every day and receive pembrolizumab by intravenous infusion every 3 weeks Continue treatment until disease progression, unacceptable side effects, or withdrawal from the study Visit the clinic regularly for physical examinations, imaging tests, blood tests, and safety assessments

Surgery vs. Watch-and-Wait Strategy in Complete Responders for Hepatocellular Carcinoma (SWITCH)

The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.

A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).

Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus

For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows: First, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).

Needle-based Percutaneous Ablation of Liver Tumors.

The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are: 1. Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely? 2. What medical problems do participants experience when receiving INT001? Participants will: Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.

Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.

Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma

The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is: Does AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies? Researchers will compare AST-3424 to regorafenib (current optional therapy for target patients) to see if AST-3424 works. Participants will: Receive AST-3424 infusion on Day 1 and Day 8 of each 21-day treatment cycle or take regorafenib once a day on Day 1 -Day 21 of each 28-day treatment cycle.

The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant/Conversion Immunotherapy in Patients With Primary Resectable Liver Cancer

On the basis of previous studies, this study intends to explore the efficacy of preoperative oral administration of Lactobacillus reuteri (Lr) combined with preoperative neoadjuvant/conversion therapy in patients with primary resectable hepatocellular carcinoma (HCC). We hypothesize that this combination represents a novel, microbiota-based therapeutic strategy to facilitate perioperative hepatic recovery and improve long-term survival outcomes. This study is an open-label, randomized, blank-controlled clinical trial. Patients undergoing liver resection were randomly allocated to one of two groups. The intervention group received preoperative oral Lactobacillus reuteri (Lr) supplementation alongside neoadjuvant/conversion immunotherapy. The control group received preoperative neoadjuvant/conversion immunotherapy alone. Fecal and peripheral blood samples will be collected at baseline (pre-medication), 3 days prior to surgery, and at 5 days, 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Intraoperative liver tissue samples will also be obtained. Statistical analyses will be performed to compare intergroup differences in postoperative liver function recovery, overall survival, hepatic and peripheral immune markers, and gut microbiota composition. This study aims to develop adjuvant strategies to enhance therapeutic outcomes for HCC patients undergoing preoperative neoadjuvant/conversion immunotherapy.

Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study

Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to our knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.

The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD

This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.

Study of GV20-0251 in Participants With Solid Tumor Malignancies

This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.

ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC

This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.