Suspended
A Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With Sintilimab Injection Plus Endostar in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
From 18 to 75 Years
+31 Eligibility Criteria
How is the trial designed
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Observational
Study Start: March 2019
Summary
Principal SponsorHuazhong University of Science and Technology
Study ContactXianglin Yuan, MD,PhDMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Study start date: March 5, 2019
Actual date on which the first participant was enrolled.For the first line treatment with untreated locally advanced or metastatic hepatocellular carcinoma, sintilimab injection plus endostar might be one of the treatment choices.
Official TitleA Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With Sintilimab Injection Plus Endostar in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Principal SponsorHuazhong University of Science and Technology
Study ContactXianglin Yuan, MD,PhDMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
2 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial
Criteria
13 inclusion criteria required to participate
Able and willing to comply with the study plans in this protocol and sign the informed consent;
Age of 18-75 years;
Cytological or histological diagnosis of untreated locally advanced or metastatic hepatocellular carcinoma;
Diseases are not suitable for radical surgery and/or local treatment, or disease progression occurs after surgery and/or local treatment;
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18 exclusion criteria prevent from participating
History of PIA meningitis;
Systemic HCC treatment has been received in the past;
History of primary immunodeficiency is known;
It is known to have active tuberculosis;
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center