Clinical Trials for Liver Cancer

Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with unresectable HCC not eligible for curative therapy (Child-Pugh A/B7, ECOG 0–2) and at least one TACE-amenable lesion receive TACE (up to 3 sessions) plus a single priming dose of nivolumab/ipilimumab followed by maintenance nivolumab and cabozantinib 40 mg daily. Cabozantinib is a multi–tyrosine kinase inhibitor (MET/VEGFR2/AXL) combined here with PD‑1 and CTLA‑4 blockade to enhance locoregional and systemic antitumor activity.

ClinicalTrials.gov ID: NCT04472767

A Phase I/II Study of Nivolumab Plus 5-Fluorouracil Plus Interferon-α2b for Unresectable Fibrolamellar Hepatocellular Carcinoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Single-center, single-arm study for adolescents and adults with unresectable fibrolamellar HCC, ECOG 0–1 and Child-Pugh A, excluding prior PD-1 for FLHCC and active autoimmune/hepatitis. Patients receive 5-FU plus interferon-α2b with nivolumab (anti–PD-1 checkpoint inhibitor) added from cycle 3, continuing in 28-day cycles up to 2 years to assess safety and preliminary efficacy, including potential conversion to resection.

ClinicalTrials.gov ID: NCT04380545

A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced, metastatic, or unresectable solid tumors or relapsed/refractory hematologic malignancies without standard options, including cohorts with normal, moderate, or severe hepatic impairment, receive oral tazemetostat 800 mg (EZH2 histone methyltransferase inhibitor) with PK-intensive sampling. Continued twice-daily dosing in 28-day cycles is allowed until progression or intolerance.

ClinicalTrials.gov ID: NCT04241835

Study of Intratumoral Injection of Dendritic Cells After High-Dose Conformal External Beam Radiotherapy in Patients With Unresectable Liver Cancer

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with unresectable primary liver cancer confined to the liver (ECOG 0–1) receive high-dose conformal EBRT followed by intratumoral autologous dendritic cell injections (with intramuscular Prevnar as an immune adjuvant); tumors must be accessible for ultrasound-guided injection. The HCC cohort also adds atezolizumab (anti–PD‑L1) plus bevacizumab (anti‑VEGF) to the DC/EBRT regimen.

ClinicalTrials.gov ID: NCT03942328

A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced/metastatic solid tumors and ECOG 0–2, including a cohort with moderate hepatic impairment (bilirubin >1.5×–≤3× ULN), receive sacituzumab govitecan-hziy (Trop-2–targeted ADC delivering SN-38) on Days 1 and 8; dose-escalation (5→7.5→10 mg/kg) is tested in the impaired-liver cohort with a normal-liver comparator at 10 mg/kg. Excludes recent irinotecan, active CNS disease, Gilbert’s syndrome, strong UGT1A1 modulators, and significant liver-related complications in the impaired cohort.

ClinicalTrials.gov ID: NCT04617522

A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with unresectable hepatocellular carcinoma or liver-only metastases receive Y-90 radioembolization (TheraSphere) followed by PET-CT–guided SBRT boost to underdosed tumor regions, with strict liver function and no progressive extrahepatic disease required. Aims to assess hepatic decompensation risk and early local control using adaptive dosimetry.

ClinicalTrials.gov ID: NCT04518748

First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced primary liver cancers (HCC or cholangiocarcinoma) or solid tumors with liver‑predominant metastases (≤2 extrahepatic sites), ECOG 0–1, receive oral AU409 in 28‑day cycles. AU409 is a first‑in‑class small‑molecule RNA transcription modulator designed to alter liver cancer transcription programs; key exclusions include untreated/symptomatic CNS metastases, significant cardiac risk, Child‑Pugh ≥B7 (for HCC), and strong CYP inducer/inhibitor use.

ClinicalTrials.gov ID: NCT05791448

Phase I Study of GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Hepatocellular Carcinoma (HCC)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with advanced, GPC3-positive hepatocellular carcinoma (≥25% by IHC) who have progressed on or are intolerant to first-line therapy receive lymphodepleting fludarabine/cyclophosphamide followed by a single infusion of autologous GPC3-targeted CAR-T cells (humanized anti-GPC3 hYP7) that recognize glypican-3 to mediate tumor cell killing. Key exclusions include Child-Pugh B/C and uncontrolled comorbidities; controlled HBV/HCV and stable treated brain metastases are allowed.

ClinicalTrials.gov ID: NCT05003895

A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults <70 with metastatic gastrointestinal or peritoneal tumors (esophageal, gastric, colorectal, liver, pancreatic) refractory to standard therapy, with at least one lesion amenable to intratumoral injection. Single intratumoral dose of vvDD-hIL2-2-RG-1, an oncolytic vaccinia virus (double-deleted TK/VGF) engineered to express membrane-tethered IL-2 to promote localized T-cell activation and oncolysis; no combination therapy in this first-in-human, single-dose escalation.

ClinicalTrials.gov ID: NCT07001592

A Phase I Study of SBRT Vaccination With Atezolizumab and Bevacizumab for Patients With Advanced Hepatocellular Carcinoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with unresectable/ablation-ineligible advanced hepatocellular carcinoma requiring systemic therapy receive concurrent stereotactic body radiotherapy (escalating doses) plus atezolizumab (anti–PD-L1) and bevacizumab (anti-VEGF). Designed to assess safety and preliminary efficacy of the triplet and define the SBRT dose to combine with this standard immunotherapy/anti-angiogenic regimen.

ClinicalTrials.gov ID: NCT05488522