Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Yi-Hsiang Huang, M.D. Ph.D.

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence in HCC management to physicians in the region, and to support the application of deTACE in treating advanced HCC patients.

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence on deTACE in HCC management to physicians in the region, and to support the application of in treating advanced HCC patients.

1. Primary Objective:

   To collect 1-year overall survival of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients in Taiwan.
2. Secondary Objectives:

   1. To evaluate the overall tumor response of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients. The tumor response is according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
   2. To evaluate the local tumor response (in the tumor(s) treated with drug-eluting microsphere) by chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
   3. To evaluate the safety profile of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
3. Exploratory Objectives:

   1. To evaluate the downstaging and downsizing potential of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients to within Milan Criteria and to within Resection margin.
   2. To collect time-to-progression (TTP) and progress-free-survival (PFS) data of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.

Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients

Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients: Safety & Efficacy Registry in Taiwan (SUPER- Taiwan)

To define all participants from the day of the first HepaSphere Treatment until tumor progression or death is first reported, whichever comes first.

Tumor staging will be accessed according to BCLC staging system and Milan criteria, and will be reviewed at follow-up until end of study or death.

To define all participants from the day of the first HepaSphere Treatment until end of study or death is reported, whichever comes first.

Tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis under CT/ MRI and will be presented as %.

Adverse event will be accessed according to CTCAE 4.0 after treatments until end of study or death.

National Taiwan University Hospital

Tri-Service General Hospital

China Medical University Hospital

Chang Gung Memorial Hospital

Taipei Veterans General Hospital, Taiwan

Professor Yi-Hsiang Huang

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

cadonilimab(10mg/kg, iv,Q3W,D1) + regorafenib(80mg,PO,QD,everyday)

Cadonilimab+regorafenib

To evaluate the efficacy and safety of cadonilimab combined with regorafenib in patients with HCC who progressed on systemic therapy.

Currently, second-line treatment options for advanced HCC (aHCC) patients including single TKI or anti-PD-(L)1 remains limited survival benefits and objective responses. To explore more effective and safer second-line or later therapies for aHCC is necessary. Cadonilimab is a first-in-class humanized IgG1 bispecific antibody that binds to PD-1 and CTLA-4 simultaneously. Dual checkpoint inhibition of the PD-1 and CTAL4 pathways with single cadonilimab has the potential to boost immune surveillance in HCC. Previously data indicated that cadonilimab possesses an encouraging anti-tumour activity and an improved safety profile compared to the co-administration of anti-PD-1 plus anti-CTLA-4 antibodies. Regorafenib is a TKI and approved for second-line treatment of uHCC globally. Here, the investigators evaluated the safety of cadonilimab plus regorafenib as second-line or later therapy in patients with aHCC.

A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC

Cadonilimab Combined With Regorafenib for Patients With Hepatocellular Carcinoma Who Progressed on Systemic Therapy: An Open Label, Single Arm, Single Center, Prospective, Phase I/II Trial

Defined as proportion of patients who have CR, PR or SD according to RECIST v1.1

Defined as the time from enrollment to disease progression or death (whichever occurs first)

Defined as the time from enrollment to death from any cause

Defined as proportion of patients who have CR, PR or SD according to mRECIST

Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

Sun Yat-sen University

Clinical Professor

Anti-Infective Agents

Antineoplastic Agents

Sirolimus

Sorafenib

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.

200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion.

Sorafenib:

Kate Kelley, MD

This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly plus sorafenib 200 mg (oral, twice daily).

The hypothesis of this single-arm phase II study is that the combination of temsirolimus and sorafenib will achieve a clinically-meaningful median time to progression (TTP) of at least 6 months, with null hypothesis of less than or equal to 3 months, in first-line systemic therapy for patients with advanced Hepatocellular carcinoma (HCC). A randomized trial would be required to formally compare the efficacy of this combination to sorafenib alone and will be indicated if this phase II study achieves a median TTP of at least 6 months. An interim safety analysis will employ stopping rules after 30% of planned patients have been treated with at least one dose of protocol therapy to ensure the combination does not confer excessive toxicity.

A key aspect of this study will be the requirement of histologic confirmation along with adequate archival tissue for correlative tissue analyses to explore new biomarkers of response to mammalian target of rapamycin (mTOR) inhibition. Circulating biomarker data including enumeration of circulating tumor cells (CTC) and measurement of the tumor marker Alpha-fetoprotein (AFP) will be performed at specific time points to evaluate for predictive value. Specimen banking of tissue, serum, and peripheral blood mononuclear cells will be undertaken to enable future novel biomarker studies. Modified RECIST will be performed in addition to standard RECIST 1.1 to explore for improved imaging predictors of response.

Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma

Phase II Trial of the Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma

Median TTP will be calculated in months from date of first dose of protocol therapy to date of removal from study for progression, where progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter of the target lesions (SLD), taking as reference the smallest sum of the SLD recorded since the treatment started and minimum 5 millimeter (mm) increase over the nadir, or the appearance of one or more new lesions for target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions . Kaplan-Meier methods will be used to summarize the primary endpoint

Response Rate (RR) is defined as any patient whom has a documented complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Results will be reported by number of participants for each response type: CR or PR.

Median PFS will be calculated in months from date of first dose of protocol therapy to date of documented disease progression or death from any cause, where progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the SLD of target lesions, taking as reference the smallest sum of the SLD recorded since the treatment started and minimum 5 millimeter (mm) increase over the nadir, or the appearance of one or more new lesions for target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Kaplan-Meier methods will be used to summarize time-to-event outcomes.

Median OS for all enrolled patients (intention-to-treat) will be calculated from date of first dose of protocol therapy until date of death, using chart review and/or follow up phone calls to determine date of death in patients after removal from study. The survival of patients still alive after 5 years of follow up post study discontinuation will be censored.

TTF will be measured from date of first dose of protocol therapy to date of study discontinuation for progression, death, or toxicity.

In patients with baseline AFP \>= 20 ng/mL, AFP response will be measured by the percent change from baseline value to the value at the time of best AFP response. The number of participants with ≥ 50% decline from baseline will be measured.

The number of patients whom required a dose reduction due to toxicity as classified by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported

The number of patients whom required a treatment delay due to toxicity as classified by the CTCAE version 4.0 will be reported

The number of participants whom discontinued treatment due to toxicity as classified by the CTCAE version 4.0 will be reported

Robert H. Lurie Cancer Center

Pfizer

University of California, San Francisco

Only patients actively treated with a combination of Temsirolimus and Sorafenib were evaluated for safety.

Combination temsirolimus plus sorafenib

Temsirolimus: 10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.

Sorafenib:: 200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion.

Treatment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

< 400 nanograms per millilitre (ng/mL)

>= 400 ng/mL

Baseline Alpha-fetoprotein (AFP)

Dr. R. Katie Kelley, MD

Median Time to Progression (TTP)

Complete Response

Partial Response

Response Rate (RR)

Median Progression Free Survival (PFS)

Median Overall Survival (OS)

Time to Treatment Failure (TTF)

Only 21 patients had AFP response data available at time of best AFP response

Number of Patients With a Demonstrated Alpha-fetoprotein (AFP) Response

Number of Patients Whom Required a Dose Reduction

Number of Patients Whom Required a Treatment Delay

Number of Participants Whom Discontinued Treatment Due to Intolerable Toxicity

Overall Study

Immunomodulating Agents

The treatment will be started within 1 week after being admitted into the trial. IMRT or SBRT are adopted , and dose of radiation: Dt-PGTV=40Gy/10fractions,Dt-PGTV=30Gy/10fractions,Dt-PGTV=20Gy/10fractions ,and so on.200mg/ of Carelizumab for injection will be given intravenously every 3 weeks for 5 times since the first day of radiotherapy until disease progression, or intolerable toxicity.

Radiation therapy and systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma

Bang-De Xiang, MD

Jian-Xu Li, MD

Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Approximately 70-80% of newly diagnosed HCC patients already have advanced disease. Sorafenib and lenvatinib are recommended as first-line options for advanced HCC, the median overall survival of the patients with advanced HCC receiving sorafenib reached 10.7 months. Based on the results of phase II clinical studies and the recommendation of guidelines, the PD-1 monoclonal antibody, such as nivolumab and pembrolizumab, have been approved to treat the patients with advanced HCC by the FDA. PD-1 monoclonal antibody has been recommended as a second-line therapeutic strategy for HCC in the 2018 CSCO guidelines for the diagnosis and treatment of primary liver cancer. However, the results of existing studies indicate that the objective response rate (ORR) of first-line PD-1 antibody therapy for patients with advanced liver cancer is about 20%.

There is a growing recognition of radiation-induced cancer cells-external tumor control mechanisms, in which radiation therapy(RT) contributes not only to local control of target lesions, but also to the control of metastases away from the treatment site. In recent years, RT combined with immunotherapy as a new treatment method has achieved certain curative effect in some patients with metastatic cancer. Therefore, it is interesting to investigate the efficacy of combining radiation therapy plus systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma.

RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)

Combining Radiation Therapy With Anti-PD-1 for Patients With Advanced Hepatocellular Carcinoma (RT+PD-1-HCC)

Guangxi Medical University

Professor

Hematinics

Liver Extracts

Autologous T cells transduced with lentivirus encoding an ET140203 expression construct

ET140203 autologous T cell product

Pei Wang, PhD

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140203 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges.

Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)

An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-1)

Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion

Safety of ET140203T cells as assessed by the severity of adverse events (AEs) after infusion.

Tolerability of ET140203T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLT, and secondarily on the best tumor response

Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.

Assess the persistence of ET140203 T cells circulating in blood over time

Eureka Therapeutics Inc.

Heart and Blood Diseases

Hypertension

Hypertension, Portal

Thrombosis

Vascular Diseases

Embolism

Embolism and Thrombosis

Patients were treated with TIPS plus Cadonilimab (10mg/kg, intravenously, d1, Q3W) to a maximum total cycle of 18 unless any evidence of disease progression or unacceptable side effects.

Cadonilimab

transjugular intrahepatic portosystemic shunt (TIPS)

Fei Gao, M.D.，Ph.D.

Han Qi, M.D.

The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension. Subjects who meet the admission criteria will be treated with Cadonilimab after TIPS until disease progression, intolerable toxicity, death, withdrawal of the patient, or the researchers determined that the drug must be discontinued.

The primary outcome measure is to evaluate the objective response rate (ORR). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events.

TIPS Plus Cadonilimab in Advanced HCC With Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study

TIPS Plus Cadonilimab (a PD-1/CTLA-4 Bispecific Antibody) in Advanced Hepatocellular Carcinoma With Tumor Thrombosis-associated Portal Hypertension: a Prospective, Single-arm, Phase II Study

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST.

DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST

The progression-free survival time (mPFS) defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST.

OS is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients	NCT03273608	Hepatocellular ...		20 Years -	Taipei Veterans General Hospital, Taiwan
A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC	NCT05773105	Advanced Hepato...	Cadonilimab+reg...	18 Years - 75 Years	Sun Yat-sen University
Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma	NCT01687673	Hepatocellular ...	Temsirolimus Sorafenib:	18 Years - 85 Years	University of California, San Francisco
RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)	NCT04193696	Hepatocellular ...	Radiation thera...	18 Years - 70 Years	Guangxi Medical University
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)	NCT04502082	Hepatocellular ... Liver Cancer Liver Neoplasm Metastatic Live...	ET140203 autolo...	18 Years -	Eureka Therapeutics Inc.
TIPS Plus Cadonilimab in Advanced HCC With Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study	NCT05882370	Hepatocellular ...	Cadonilimab transjugular in...	18 Years - 75 Years	Sun Yat-sen University
RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)	NCT04193696	Hepatocellular ...	Radiation thera...	18 Years - 70 Years	Guangxi Medical University
TIPS Plus Cadonilimab in Advanced HCC With Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study	NCT05882370	Hepatocellular ...	Cadonilimab transjugular in...	18 Years - 75 Years	Sun Yat-sen University
Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients	NCT03273608	Hepatocellular ...		20 Years -	Taipei Veterans General Hospital, Taiwan
Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients	NCT03273608	Hepatocellular ...		20 Years -	Taipei Veterans General Hospital, Taiwan

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