Clinical Trials for Liver Cancer

vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

TrialFetch AI summary: Adults with unresectable, locally advanced or metastatic HCC (or mixed HCC-CCA), ECOG 0–1 and Child-Pugh A–B7, receive a single-fraction vGRID SBRT dose-escalation (27–47 Gy; de-escalation to 40 Gy in 5 fractions if needed) targeting part of the tumor with high dose while respecting liver/GI constraints. Standard atezolizumab (PD-L1 inhibitor) starts 12–16 days post-SBRT with bevacizumab held for cycle 1 to reduce GI risk.

ClinicalTrials.gov ID: NCT05727787

Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid 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.

TrialFetch AI summary: Adults with metastatic solid tumors involving lung and/or liver (≥2 measurable lesions; prior PD-1/PD-L1 allowed) receive intratumoral NBTXR3 (hafnium oxide radioenhancer nanoparticles) injected into a lung or liver lesion plus anti–PD-1/PD-L1 therapy, randomized to either high-dose RT to one lesion only (abscopal) or high-dose RT to one lesion plus low-dose RT to additional lesions (RadScopal). Excludes prior RT to the high-dose target lesion, uncontrolled CNS disease, significant unresolved irAEs/radiation toxicities, active autoimmune disease requiring systemic therapy, and uncontrolled infections.

ClinicalTrials.gov ID: NCT05039632

The Role of Checkpoint Inhibition in Relapsed/Refractory Pediatric Hepatocellular Carcinoma: Clinical Efficacy and Biologic Correlates - A Phase II Study

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

TrialFetch AI summary: Single-arm study of pembrolizumab (anti–PD-1) given IV q3 weeks in children, adolescents, and young adults (<30 years) with relapsed/refractory hepatocellular carcinoma or hepatocellular neoplasm NOS, requiring measurable disease and adequate performance/organ function. Excludes prior checkpoint inhibitor therapy, active autoimmune disease, chronic immunosuppression, and prior solid organ transplant; assesses responses by irRECIST with planned tumor/immune biomarker correlatives.

ClinicalTrials.gov ID: NCT04134559

Phase II Trial of Palliative Hypofractionated Radiotherapy Followed by Durvalumab (MEDI4736) With/Without Tremelimumab for Advanced Hepatocellular Carcinoma After Progression on Prior PD-1 Inhibition

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

TrialFetch AI summary: Adults with advanced HCC (ECOG 0–1, Child-Pugh A–B8) requiring palliative RT who have progressed on prior anti–PD-1 therapy (no prior PD-L1/CTLA-4) receive short-course hypofractionated RT followed by durvalumab (anti–PD-L1) with or without tremelimumab (anti–CTLA-4). Excludes active autoimmune disease or significant unresolved irAEs; evaluates responses in non-irradiated lesions with optional tremelimumab re-dose at progression after initial benefit.

ClinicalTrials.gov ID: NCT04430452

Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells

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.

TrialFetch AI summary: For pediatric and young adult patients with relapsed/refractory non-CNS solid tumors confirmed to express glypican-3 (including hepatocellular carcinoma meeting Barcelona stage A–C and Child-Pugh <7), this study tests autologous GPC3-targeted CAR T cells “armored” with IL-15 and IL-21 to enhance expansion/persistence. Patients receive cyclophosphamide/fludarabine lymphodepletion followed by a single IV infusion of SC-CAR.GPC3xIL15.21 with dose escalation, with an inducible caspase-9 safety switch that can be activated using rimiducid for severe toxicity.

ClinicalTrials.gov ID: NCT07148050

A Phase I/II Study of Tebentafusp-tebn in Combination With Liver-Directed Therapies for the Treatment of Metastatic Uveal Melanoma

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.

TrialFetch AI summary: Enrolling HLA-A*02:01–positive adults with metastatic uveal melanoma involving the liver (≥1 measurable liver lesion), ECOG 0–1; Part 1 focuses on low–moderate hepatic burden and no prior systemic therapy in the metastatic setting, while Part 2 includes bulky liver-dominant disease (largest lesion >5 cm and/or ≥50% liver involvement) and allows up to 2 prior systemic/liver-directed lines (excluding prior tebentafusp and prior chemoembolization). Patients receive weekly step-up tebentafusp-tebn (gp100/HLA-A*02:01–directed ImmTAC that redirects T cells via anti-CD3) alone or combined with hepatic immunoembolization plus GM-CSF (randomized vs tebentafusp alone in Part 1B), or sequential BCNU (carmustine) transarterial chemoembolization followed by tebentafusp in bulky disease (Part 2).

ClinicalTrials.gov ID: NCT06626516

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients With Metastatic Breast Cancer With Liver Dominant Disease

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.

TrialFetch AI summary: Adults with HER2-negative metastatic breast cancer (including triple-negative) and liver-dominant measurable metastases (≤50% liver involvement, limited extrahepatic disease; ECOG 0–1) who have progressed on endocrine therapy + CDK4/6 if HR+ and generally after/unsuitable for a topo-1 payload ADC are randomized to liver-directed induction with melphalan via hepatic arterial infusion using the Melphalan/HDS extracorporeal filtration system (DNA-alkylating/crosslinking agent; aims to boost intrahepatic exposure while limiting systemic toxicity) for up to 2 cycles followed by single-agent chemotherapy (eribulin, vinorelbine, or capecitabine) vs the same physician’s-choice single-agent chemotherapy alone. Primary outcome is hepatic progression-free survival.

ClinicalTrials.gov ID: NCT06875128

AD HOC Trial: Artificial Intelligence-Based Drug Dosing In 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.

TrialFetch AI summary: Adults with biopsy-proven advanced hepatocellular carcinoma (or LI-RADS 5) who are not candidates for curative/locoregional therapy or have progressed after it (ECOG 0–2; Child-Pugh A or B7; measurable disease) receive dose-escalated triple therapy with sorafenib (oral multikinase/VEGFR pathway inhibitor) plus sonidegib (oral Hedgehog pathway SMO inhibitor) plus irinotecan (IV topoisomerase I inhibitor). This single-arm study determines the maximum tolerated dose over 32 days with AI/phenotypic and ctDNA-informed individualized dosing; UGT1A1*28 homozygotes are excluded.

ClinicalTrials.gov ID: NCT05669339

A Phase 1b/2 Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of Melphalan Percutaneous Hepatic Perfusion Therapy (HEPZATO KIT™) With Nivolumab and Relatlimab (Opdualag) in Patients With Metastatic Melanoma and Liver Metastasis

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.

TrialFetch AI summary: For adults with unresectable/metastatic melanoma with biopsy-confirmed liver metastasis who are systemic-treatment naïve in the metastatic setting (prior adjuvant anti–PD-1 and/or BRAF/MEK allowed if >6 months), this study combines liver-directed melphalan percutaneous hepatic perfusion via the HEPZATO KIT (temporary hepatic vascular isolation with extracorporeal filtration to limit systemic exposure) with fixed-dose Opdualag (nivolumab PD-1 blockade plus relatlimab LAG-3 blockade to enhance T-cell activation). It evaluates safety and preliminary systemic and hepatic antitumor activity.

ClinicalTrials.gov ID: NCT07281924

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

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.

TrialFetch AI summary: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381