Heart and Blood Diseases

All Conditions

Neoplasms

Digestive System Diseases

Hypertension

Carcinoma

Carcinoma, Hepatocellular

Hypertension, Portal

Thrombosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Vascular Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Embolism

Embolism and Thrombosis

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

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.

Fei Gao

Clinical Professor

Symptoms and General Pathology

Hemorrhage

Varicose Veins

Antineoplastic Agents

Oxaliplatin

Patients in the endoscopic treatment group receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices.

Patients in the TIPS group receive transjugular intrahepatic portosystem stent-shunt.

Patients in the endoscopic treatment receive endoscopic variceal ligation and N-butyl-cyanoacrylate according to the type of varices

Endoscopic treatment

Patients in the TIPS group receive Transjugular Intrahepatic Portosystemic Shunt

TIPS

Xiaoquan HUANG, M.D.

Xiaoquan HUANG

Shiyao CHEN

Liyuan NI

Shiyao CHENCHEN, M.D. & Ph.D

In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial

Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours

Other complications of portal hypertension such as the progression of ascites, liver failure, etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
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
Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding	NCT05141617	Gastroesophagea... Gastrointestina... Received Oxalip...	Endoscopic trea... TIPS	18 Years - 75 Years	Shanghai Zhongshan Hospital

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Spots Global Cancer Trial Database for tips

Every month we try and update this database with for tips cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tips cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.