Clinical Research Directory

HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma

The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.

Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC

open-label trial of an allogeneic dual-target CAR-NK product directed against GPC3 and B7-H3 for adults with advanced hepatocellular carcinoma. The design intentionally uses GPC3 as the primary target anchor because GPC3 is the dominant HCC cell-therapy antigen in current clinical development, while adding B7-H3 to reduce antigen escape and to broaden coverage across tumor and tumor-microenvironment compartments. The study first evaluates safety and dose-limiting toxicities, then expands at the recommended phase 2 dose.

An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

Phase 2 Study of WGI-0301 for Advanced HCC

The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.

A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)

This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.

Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes

the Objectives of this study are: • Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors. the main question it aims to answer is: What are the clinical outcomes (overall survival, progression-free survival, and OS-ICIs) of immune checkpoint inhibitor therapy in patients with advanced hepatocellular carcinoma? Participants already taking immune checkpoint inhibitors as part of their regular medical care.

A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion

In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.

Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer

This trial is an open-label, dose-escalation, and randomized controlled Phase Ib/II clinical study for second-line treatment in participants with advanced hepatocellular carcinoma (HCC). Its primary objective is to evaluate the safety, tolerability, pharmacokinetic profiles, and efficacy of transcatheter arterial infusion of HA131 combined with systemic therapy in the second-line treatment of participants with advanced HCC.

Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC

This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC. Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group).

A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma

This study is a prospective, single-arm, open, single-center clinical trial initiated by the investigator. The principal investigators are professors Shen Feng and Zhang Xiaofeng from The Third Affiliated Hospital of Navy Military Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital). Primary Objectives: 1. To evaluate the safety and tolerability of super Hi-TCR-T cells targeting Nectin4/NKG2DL/TROP2/B7H3/GPC3/FAP in the treatment of refractory/recurrent advanced hepatocellular carcinoma (HCC) and other solid tumors. 2. To assess the efficacy of super Hi-TCR-T cells targeting Nectin4/NKG2DL/TROP2/B7H3/GPC3/FAP in the treatment of refractory/recurrent advanced HCC and other solid tumors, focusing on progression-free survival (PFS). Secondary Objectives: 1. To evaluate the efficacy of super Hi-TCR-T cells targeting Nectin4/NKG2DL/TROP2/B7H3/GPC3/FAP in the treatment of refractory/recurrent advanced HCC and other solid tumors at 1, 3, 6, and 12 months, assessing disease control rate (DCR: CR+PR+SD), time to progression (TTP), and overall survival (OS). 2. To observe and assess the quality of life (QOL score) of patients receiving super Hi-TCR-T cell therapy targeting Nectin4/NKG2DL/TROP2/B7H3/GPC3/FAP for refractory/recurrent advanced HCC and other solid tumors. Exploratory Objectives: 1. To evaluate the relationship between the in vivo expansion and persistence of super Hi-TCR-T cells targeting Nectin4/NKG2DL/TROP2/B7H3/GPC3/FAP and disease progression. 2. To explore potential predictive biomarkers. Thirty patients are planned to be recruited for this study. The subjects were advanced HCC patients who had failed second-line therapy or could not tolerate therapy. The expression levels of Nectin4, NKG2DL, TROP2, B7H3, GPC3 and FAP were detected by immunohistochemistry in the pathologic tissues of the primary and metastatic sites. Meanwhile, 20ml peripheral blood was extracted to evaluate the quality of T cells (in vitro proliferation activity and lentiviral transduction efficiency). Patients with positive expression rates of at least 2 targets (excluding FAP) \>10% and qualified T cell quality could be considered for inclusion. Peripheral blood lymphocytes were collected and Hi-TCR-T cells targeting three targets (including FAP) were prepared. After pretreatment with fludarabine + cyclophosphamide chemotherapy (FC regimen), the prepared Hi-TCR-T cells were transfused back, in which the dose of Hi-TCR-T cells at each target was 3.0x106 cells/kg body weight (the dose was the extended therapeutic dose obtained in the previous clinical trial), and the drug was administered by peripheral intravenous infusion. To improve efficacy, Hi-TCR-T cell retransfusion can be prepared by increasing the cell dose of the target or changing the combination of the target as the disease progresses and evaluated by a multidisciplinary team (MDT). Safety and efficacy evaluation and exploratory studies were conducted after reinfusion of Hi-TCR-T cells from screening multiple targets: 1. Safety assessment: at baseline, 4, 7, 10, 2, 3, 4, 8, 12, 16, 20, 6, 9 and 12 months after cell therapy; 2. Effectiveness evaluation: at baseline, 4, 12, 6, 9, 12, 24, and 36 months after cell therapy. Safety assessment: At baseline, 4, 7, 10, 2, 3, 4, 8, 12, 16, 20, 6, 9, and 12 months after cell therapy; 3. Exploratory study: 20ml peripheral blood was collected from patients at baseline, 7 days, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 6 months, 9 months, 12 months after cell therapy, to explore the relationship between the proliferation and survival time of Hi-TCR-T cells in vivo and the changes of disease and peripheral blood cytokines. The start time of the study was defined as the date the first patient was enrolled; The end time of the study was defined as 12 months after the end of medication for the final patient, or all patients died, or all patients had lost follow-up or withdrawn consent (whichever occurred first). The planned recruitment period is 12-18 months.

Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma

The goal of this open-label, single-arm phase I/II clinical trial is to evaluate the feasibility, safety, and anti-tumor efficacy of the autologous neoantigen-specific T-cell therapy (iNeo-Vac-T01) in patients with advanced hepatocellular carcinoma who have failed second-line or later systemic therapies.

Personalized Tumor Neoantigen mRNA Therapy for Advanced Hepatocellular Carcinoma

This study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody, anti-VEGFR monoclonal antibody and TACE regimen for the treatment of patients with advanced hepatocellular carcinoma.

A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.

Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma

This is a prospective, randomised controlled clinical trial to study the impact of prehabilitation on postoperative complications, physical function, quality of life, and short-term survival outcomes in patients with unresectable liver cancer undergoing conversion therapy.