What side effects are associated with this type of intervention?

Common treatments for liver cancer, particularly those targeting hepatitis B virus-related hepatocellular carcinoma, include antiviral therapies, molecular targeted therapies, and immunotherapies. Antiviral therapies, such as nucleos(t)ide analogs, can cause side effects like fatigue, headache, and gastrointestinal issues. Molecular targeted therapies, such as sorafenib, may lead to hand-foot skin reactions, diarrhea, hypertension, and fatigue. Immunotherapies can result in immune-related adverse effects, including skin rash, colitis, hepatitis, and endocrinopathies. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

Sorafenib, approved in 2006, was the first systemic therapy for advanced hepatocellular carcinoma (HCC), targeting RAF kinase and VEGFR. More recently, the combination of atezolizumab and bevacizumab has shown efficacy in treating unresectable HCC. These treatments, along with ongoing research into molecularly-targeted therapies and immunotherapies, represent significant advancements in HCC management. The SCG101 trial, focusing on hepatitis B virus-related HCC, likely explores similar antiviral or anticancer pathways.

What other types of research exist?

Promising novel alternatives to SCG101 for liver cancer patients include: 1) Rigosertib, which inhibits both PLK1 activation and major RAS-pathways, offering a 'dual-hit' approach for HCC. 2) Combined resveratrol and silymarin, which targets the MTOR signal cascade associated with HBV-related HCC. 3) Molecular strategies inhibiting the CXCR4/SDF-1 pathway, which may be useful in treating HCC. 4) Combination therapy of LCL161 and SC-2001, which targets Bcl-2 to overcome drug resistance in HCC cells. 5) Targeted inhibition of NEIL3, which is involved in the BRAF/MEK/ERK/TWIST signaling pathway and HCC progression.

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Virus Therapy

SCG101 for Liver Cancer (TCR-T Trial)

Phase 1 & 2

Recruiting

Research Sponsored by SCG Cell Therapy Pte. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)

Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria

Must not have

Subjects with history of another primary cancer

Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of scg101 infusion and throughout dlt and pfs until disease progression, an average of 24 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests SCG101, a new treatment, for safety and effectiveness in patients with liver cancer related to hepatitis B. The study aims to find the best dose that patients can tolerate and how well it works against the cancer. Another treatment being tested shows greater stability and performance over earlier treatments.

Who is the study for?

This trial is for individuals with liver cancer related to hepatitis B who have tried at least two standard treatments and are expected to live at least three more months. They must have a measurable tumor, be able to consent, and not have HIV/AIDS or other cancers. People with allergies to certain immunotherapies, severe mental disorders, previous cell therapies, untreated brain metastasis, or autoimmune diseases needing strong medication can't join.

What is being tested?

The study tests SCG101's safety and effectiveness in treating hepatitis B-related liver cancer. It's an early-stage (Phase 1/2a) trial involving multiple centers where participants receive the investigational drug SCG101.

What are the potential side effects?

While specific side effects of SCG101 aren't listed here, similar drugs often cause immune reactions, fatigue, nausea, potential organ inflammation due to the immune system's response and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer diagnosis was confirmed through tissue examination.

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I have a tumor that can be measured by standard medical scans.

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My genetic makeup includes HLA-A *02.

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I have liver cancer and have undergone at least 2 standard treatments.

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My liver cancer is at an intermediate or advanced stage.

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My hepatitis B virus levels are high, but I don't have active hepatitis.

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My liver function is relatively good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had another type of cancer in the past.

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I have an autoimmune disease but don't need strong immune-suppressing drugs.

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I have not had brain metastasis, liver-related brain issues, or significant brain diseases.

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I am allergic to certain cancer drugs, including cyclophosphamide and fludarabine.

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I have a history of neurological or mental disorders like epilepsy or dementia.

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I have not had treatments like CAR T-cell therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of scg101 infusion and throughout dlt and pfs until disease progression, an average of 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of scg101 infusion and throughout dlt and pfs until disease progression, an average of 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of scg101 infusion and throughout dlt and pfs until disease progression, an average of 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of SCG101

Secondary study objectives

Antiviral activity before and after SCG101 infusion

Change in pharmacodynamic markers (PD) before and after SCG101 infusion

Preliminary clinical efficacy of SCG101

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SCG101Experimental Treatment1 Intervention

This is a single arm study. Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cancer, especially hepatitis B virus-related hepatocellular carcinoma (HCC), include antiviral therapies, targeted therapies, and immunotherapies. Antiviral therapies, such as nucleos(t)ide analogs, work by suppressing HBV replication, thereby reducing liver inflammation and the risk of cancer recurrence. Targeted therapies, like tyrosine kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapies enhance the body's immune response to identify and destroy cancer cells. These mechanisms are vital as they not only control the underlying viral infection but also directly combat cancer, improving patient outcomes and reducing the likelihood of recurrence.

Hepatitis B virus-related hepatocellular carcinoma in the era of antiviral therapy: The emerging role of non-viral risk factors.Targeted therapies in hepatocellular carcinoma.