Suspended

Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma

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What is being tested

Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs

+ Fludarabine

+ Cyclophosphamide

BiologicalDrug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 70 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: June 2017
See protocol details

Summary

Principal SponsorXinqiao Hospital of Chongqing
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2017

Actual date on which the first participant was enrolled.

Primary Objectives: 1. To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma 2. To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection Secondary Objectives: 1. To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma 2. To monitor the serum cytokine and expression level of tumor markers such as AFP, CEA and GPC3 3. To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells

Official TitlePhase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
NCT03084380
Principal SponsorXinqiao Hospital of Chongqing
Last updated: January 27, 2026
Sourced 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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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 70 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

8 inclusion criteria required to participate
Expected to survive more than 3 months
PS 0-2
Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma
Patients with no ability to receive TACE combined with sorafenib
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10 exclusion criteria prevent from participating
Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
Decompensated liver cirrhosis, liver function Child-pugh C grade
Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
Long-term use of immunosuppressive agents after organ transplantation
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion

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

Suspended

Department of Oncology, Xinqiao Hospital

Chongqing, ChinaOpen Department of Oncology, Xinqiao Hospital in Google Maps
SuspendedOne Study Center