Clinical Trials for Liver Cancer

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

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.

HealthScout AI summary: Adults with advanced solid tumors eligible for standard anti–PD-1 monotherapy (e.g., melanoma, RCC, NSCLC, HCC Child-Pugh A, MSI-H tumors, urothelial, GEJ/gastric adenocarcinoma, HNSCC) are randomized to nivolumab or pembrolizumab alone versus combined with metformin (mitochondrial complex I inhibitor/AMPK activator) or rosiglitazone (PPAR-γ agonist) to reduce tumor hypoxia and improve immune function. Requires measurable disease, ECOG 0–2, and mandatory pre/post-treatment biopsies; excludes prior PD-1/PD-L1 therapy and significant cardiopulmonary/autoimmune contraindications.

ClinicalTrials.gov ID: NCT04114136

Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody

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.

HealthScout AI summary: Adults with advanced hepatocellular carcinoma (Child-Pugh A–B7) or metastatic gastric/gastroesophageal cancer with ≥1 liver lesion, who have progressed on prior immune checkpoint inhibitor therapy (or chemo plus ICI for gastric/GE), receive nivolumab (PD‑1 inhibitor) plus transarterial tirapazamine embolization (TATE), a hypoxia-activated prodrug delivered with embolization to intensify local tumor kill and potentially augment systemic immunity. Requires ECOG 0–2 and adequate organ function; excludes recent major GI bleeding and significant autoimmune disease.

ClinicalTrials.gov ID: NCT03259867

A Phase 1, Open-label, Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors 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.

HealthScout AI summary: Adults with locally advanced or metastatic solid tumors and either moderate hepatic impairment or normal liver function receive IV nab-sirolimus (albumin-bound sirolimus, an mTORC1 inhibitor) on Days 1 and 8 of 21-day cycles. The study evaluates safety and pharmacokinetics to define the appropriate dose for patients with moderate hepatic impairment.

ClinicalTrials.gov ID: NCT05661461

A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma

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.

HealthScout AI summary: Adults with unresectable or locally recurrent hepatocellular carcinoma (AASLD/pathologic criteria, Zubrod 0–1, Child-Pugh A–B7, ≤3 liver lesions within specified size limits; portal vein involvement allowed if a single lesion 1–15 cm) are randomized to definitive radiotherapy using proton beam versus contemporary photon therapy, delivered in 5 or 15 fractions over ~3–4 weeks. The trial compares overall survival and toxicity, leveraging proton therapy’s potential to spare uninvolved liver and adjacent organs versus photons.

ClinicalTrials.gov ID: NCT03186898

Lenvatinib in Recurrent Hepatocellular Carcinoma After Liver Transplantation

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.

HealthScout AI summary: Single-arm study of lenvatinib monotherapy in adults with measurable recurrent hepatocellular carcinoma after curative-intent liver transplantation who are not candidates for resection, with ECOG 0–1 and Child-Pugh A and no prior post-transplant systemic therapy. Lenvatinib is an oral multikinase inhibitor of VEGFR1–3, FGFR1–4, PDGFRα, RET, and KIT, given daily in 28-day cycles until progression or intolerance.

ClinicalTrials.gov ID: NCT05103904

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

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.

HealthScout 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

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination with Ipilimumab Followed by Nivolumab Monotherapy in Patients with Locally Advanced or Metastatic Cancers Following One or More Prior Therapies

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: This trial involves patients with advanced or metastatic solid tumors, such as melanoma and non-small cell lung cancer, who have had prior therapies, evaluating the safety and efficacy of Alintegimod, an integrin-targeting agent, combined with ipilimumab and nivolumab.

ClinicalTrials.gov ID: NCT06362369