Clinical Trials for Liver Cancer

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

TrialFetch 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

A Phase 2, Open-label, Multicenter Study Investigating RP2 Oncolytic Immunotherapy in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable, Recurrent and/or Metastatic Hepatocellular Carcinoma

TrialFetch AI summary: Adults with unresectable, recurrent, or metastatic HCC (Child-Pugh A, ECOG 0–1) who progressed after exactly one prior PD‑1/PD‑L1–based regimen and have measurable, injectable disease receive intratumoral RP2 plus atezolizumab and bevacizumab. RP2 is an oncolytic HSV‑1 engineered to express GALV‑GP‑R−, GM‑CSF, and a locally acting anti–CTLA‑4 molecule to drive oncolysis and antitumor immunity; key exclusions include high-risk varices, Vp4/macrovascular invasion, active herpetic infection, uncontrolled HBV, and significant autoimmune or bleeding risks.

ClinicalTrials.gov ID: NCT05733598

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

TrialFetch 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

TrialFetch 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 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

TrialFetch AI summary: Enrolling adults with advanced solid tumors for dose escalation and a biomarker-selected expansion in FGF19-overexpressing BCLC B/C hepatocellular carcinoma (Child-Pugh A–B7), after or unsuitable for first-line systemic therapy. Patients receive oral irpagratinib (ABSK-011), a selective covalent FGFR4 inhibitor targeting FGF19–FGFR4 signaling, given QD or BID in 28-day cycles.

ClinicalTrials.gov ID: NCT04906434

Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer

TrialFetch AI summary: Adults with well-differentiated, liver-dominant metastatic neuroendocrine tumors (ECOG 0–1) and documented intrahepatic progression receive intra-arterial tirapazamine immediately followed by conventional TAE (Lipiodol/Gelfoam). Tirapazamine is a hypoxia-activated prodrug that generates DNA-damaging radicals and functions as a tumor-selective topoisomerase II poison under low oxygen, aiming to potentiate embolization-induced hypoxia.

ClinicalTrials.gov ID: NCT02174549

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

TrialFetch 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

Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)

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.

TrialFetch AI summary: Adults with advanced HCC (BCLC B not eligible for locoregional therapy or BCLC C) and Child-Pugh B7–B8 cirrhosis, ECOG 0–1, no prior systemic therapy, including HBV/HCV with control. Patients receive the STRIDE regimen: a single priming dose of tremelimumab (CTLA-4 inhibitor) plus durvalumab maintenance (PD-L1 inhibitor) given every 4 weeks until progression or toxicity.

ClinicalTrials.gov ID: NCT06526104

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

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

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