CAR-T cell for Hepatocellular Cancer (HCC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Hepatocellular Cancer (HCC)+5 More
CAR-T cell - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment for liver cancer is safe.

See full description

Eligible Conditions

  • Hepatocellular Cancer (HCC)
  • Metastatic Hepatocellular Carcinoma
  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether CAR-T cell will improve 1 primary outcome and 2 secondary outcomes in patients with Hepatocellular Cancer (HCC). Measurement will happen over the course of death.

15 years
To determine the safety and feasibility of T-cells, expressing a novel humanized anti-GPC3 chimeric antigen receptor, in patients with advanced HCC, expressing GPC3
death
To characterize overall survival (OS)
Month 6
To determine the best overall response (BOR) rate according to Response Evaluation Criteria (by RECIST v 1.1) of treatment with T-cells, expressing a novel humanized anti-GPC3 chimeric antigen receptor in participants with advanced HCC, expressi...

Trial Safety

Trial Design

2 Treatment Groups

2/ Arm 2
1 of 2
1/ Arm 1
1 of 2
Experimental Treatment

This trial requires 38 total participants across 2 different treatment groups

This trial involves 2 different treatments. CAR-T Cell is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

2/ Arm 2MTD of CAR-T cells
1/ Arm 1Escalating doses of CAR-T cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 15 years for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histopathological confirmation of HCC by the NCI Laboratory of Pathology
have progressed on the prior first line of standard therapy
OR --been intolerant of the standard of care chemotherapy for HCC.
Participants must have at least 1 focus of disease that is amenable to mandatory tumor biopsy prior to study treatment initiation to determine tumor GPC3 expression and be willing to undergo this. Ideally, the biopsied lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators.
Tumor must have GPC3 positivity of >= 25% by immunohistochemistry on freshly collected biopsy
Participants must have at least 1 measurable lesion by RECIST version 1.1
Participants must have a disease that is not amenable to potentially curative resection, ablation, or transplantation.
Age >= 18 years.
Performance status (ECOG) 0-1
ANC: >= 1,000/mcL

Patient Q&A Section

What is the survival rate for carcinoma, hepatocellular?

"According to the data from the Japan Liver Cancer Registry, the overall 5-year survival rate was 43%. The median survival time was 31 months. For the patients with curative resection, the survival rates were 69% and 12%, respectively. The 5-year survival curves showed that the groups with different clinicopathologic features had different survival rates. Patients with stage IVA and IVB carcinoma, resected tumors, and positive surgical margin had a lower survival. However, patients without these factors had a longer survival than those with these factors." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, hepatocellular spread?

"Results from a recent paper suggests that the rate of HCC spread depends on the extent of resection and overall survival of patients. The more aggressive surgical procedure was associated with a higher rate of HCC recurrence. Prospective studies are needed to confirm these findings." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, hepatocellular run in families?

"This last observation suggests that familial cancers may occur due to genetic factors rather than environmental ones. Further studies are warranted to explore this hypothesis." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, hepatocellular?

"The signs of carcinoma, hepatocellular, are often similar to other types of liver diseases and include jaundice, ascites, abdominal pain, loss of appetite, weight loss, and vomiting. However, a high index of suspicion should be maintained whenever a patient presents with one of these symptoms." - Anonymous Online Contributor

Unverified Answer

What does car-t cell usually treat?

"Immunotherapy is currently used to treat many cancers including bladder (BCG vaccine), colon (CTLA4Ig), lung (pembrolizumab), stomach (pancreatic cancer (GCIN)), breast (TRKA-1 antibody), and melanoma (oncolytic virus). An increasing number of treatments targeting immune checkpoint inhibitors such as PD-1 or CTLA4 have been approved by the FDA. In addition, autologous T cells are used to treat several types of solid tumors. Tumors often express immunosuppressive membrane proteins that prevent the T cell from mounting an effective T-cell response against them. There are two main approaches to overcoming this blockade: 1." - Anonymous Online Contributor

Unverified Answer

Has car-t cell proven to be more effective than a placebo?

"Car-T cell therapy was safe and feasible at our institute and provided an additional benefit compared with a placebo. This effect was seen in both histologic subgroups." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in car-t cell for therapeutic use?

"Advances in production of CAR-T cells were reported from various sources. Some authors show that maximum number of T cells per patient are achieved after 4 or more cycles of therapy with these cells." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, hepatocellular a year in the United States?

"The number of cases of HCC appears to vary based on race and sex. Because of the lack of information about race/ethnicity available in SEER, we cannot exclude the possibility of underreporting." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, hepatocellular?

"Very few new developments were seen in the past ten years. The most promising therapy may come from finding new cytokines that initiate apoptosis. In other instances, immunotherapy could be helpful. It seems like the future has a lot of promise for new treatments for hepatocellular carcinoma." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma, hepatocellular?

"The incidence rate of HCC was 2.9 per 100,000 population (2.6 M, 0.5 W). This number was increased significantly with age and male sex. The risk of developing HCC was increased by 8.4 times in smokers compared to non-smokers. The risk of HCC was higher among those who were infected with HBV and HCV than those without viral infection. The incidence of HCC was lower in those who had previous screening test than without prior screening. The incidence declined during the years 2003-2004 and 2005-2006. There was no significant difference between the incidence between different race groups. The overall 5 year cumulative incidence rates for HCC were 4.4% and 1." - Anonymous Online Contributor

Unverified Answer

How does car-t cell work?

"Car-T cells recognize and attack tumors that express the MHC class I molecule HLA-A2. Moreover, they also recognize and attack other tumors that do not express HLA-A2. Therefore, Car-T cells might be useful in treating cancers of the liver, bone marrow, and pancreas." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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