Clinical Trials for Liver Cancer

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

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 hepatocellular carcinoma with radiographic macrovascular invasion (ECOG 0–2, Child-Pugh A or B7; extrahepatic metastases allowed; no prior systemic therapy) are randomized after physician selection of a first-line IO regimen to receive systemic therapy alone versus the same systemic therapy plus liver SBRT (5 fractions). Systemic options are atezolizumab (PD-L1) + bevacizumab (VEGF), single-dose tremelimumab (CTLA-4) + durvalumab (PD-L1), or nivolumab (PD-1) + ipilimumab (CTLA-4) induction followed by nivolumab maintenance, with SBRT as the investigational addition.

ClinicalTrials.gov ID: NCT07166406

Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced HCC (RECON 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.

TrialFetch AI summary: Adults with advanced/metastatic, RECIST-measurable hepatocellular carcinoma (ECOG 0–2) and preserved hepatic function (excluding Child-Pugh ≥7B), without recent checkpoint inhibitor therapy (within 6 months) or significant cardiovascular/thromboembolic/GI bleeding risk, receive celecoxib (oral selective COX-2 inhibitor aimed at blocking COX-2/PGE2–mediated immunosuppression) continuously plus durvalumab (anti–PD-L1) every 28 days and a single priming dose of tremelimumab (anti–CTLA-4) on cycle 1 day 1. Treatment continues until progression or unacceptable toxicity with correlative biomarker sampling.

ClinicalTrials.gov ID: NCT07174570

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic 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.

TrialFetch AI summary: Adults with measurable advanced/metastatic solid tumors eligible for standard FDA-approved immune checkpoint inhibitor therapy (anti–PD-1/PD-L1 and/or anti–CTLA-4), including NSCLC, HNSCC, RCC, biliary, HCC, and melanoma, who are ICI-naive. Patients are randomized to receive their planned standard-of-care immunotherapy in the morning versus afternoon for the first 4 doses to evaluate whether administration timing affects outcomes.

ClinicalTrials.gov ID: NCT07405086

A Pilot Study of 68Ga-PSMA-11 PET-directed Radioligand Therapy in Patients With Metastatic Hepatocellular Carcinoma (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.

TrialFetch AI summary: Single-arm pilot study enrolling adults with PSMA-PET–positive metastatic or unresectable HCC after progression on one prior systemic therapy including anti–PD-L1, with ECOG 0–1 and Child-Pugh A/B7 liver function. Participants receive IV 177Lu-PSMA-617 (Lu-177 vipivotide tetraxetan) every 6 weeks, a PSMA-targeted beta-emitting radioligand directed at PSMA-expressing tumor neovasculature in HCC.

ClinicalTrials.gov ID: NCT06852820

A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC

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: This trial targets adults with stage IV NSCLC involving liver metastases, excluding those with EGFR or BRAF mutations and prior liver radiation, to evaluate the impact of adding liver stereotactic ablative radiotherapy (L-SABR) to a standard regimen of anti-PD-(L)1 based immunotherapy and optional platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT05657873

An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab

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: This trial evaluates the combination of Trans-Arterial Tirapazamine Embolization (TATE) and Pembrolizumab in patients with metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) who have liver metastases and have progressed after prior therapies. TATE delivers the hypoxia-activated prodrug Tirapazamine to liver tumors, while Pembrolizumab, an immune checkpoint inhibitor, blocks the PD-1 pathway to enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT04701476

Phase I Trial of Feasibility and Safety of Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

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: This trial investigates the safety and feasibility of combining liver SBRT with the immune checkpoint inhibitor Pembrolizumab, which targets PD-1, in adult patients with metastatic non-small cell lung cancer and liver metastases who are eligible for this immunotherapy.

ClinicalTrials.gov ID: NCT05430009

A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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 enrolls adults (ECOG 0-2) with locally advanced or metastatic cancers eligible for atezolizumab, investigating therapeutic drug monitoring-based personalized dosing of atezolizumab (anti-PD-L1 immune checkpoint inhibitor) as monotherapy or combined with other approved agents. Patients initially receive standard dosing, then transition to adaptive, lower-frequency fixed dosing based on plasma levels.

ClinicalTrials.gov ID: NCT06066138

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

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 unresectable, liver-only metastatic colorectal cancer (after 3–6 months of first-line chemotherapy, ECOG 0-1, no significant extrahepatic disease) are randomized to standard systemic chemotherapy (e.g., FOLFOX, FOLFIRI, or OX/IRI ± targeted agents) with or without hepatic arterial infusion of floxuridine, an antimetabolite delivered directly to the liver via an implanted pump.

ClinicalTrials.gov ID: NCT05863195

Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

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.

TrialFetch AI summary: This trial enrolls adults with liver-only or liver-dominant metastatic colorectal cancer, intrahepatic cholangiocarcinoma, or adrenocortical carcinoma who have progressed on prior chemotherapy, and treats them with hepatic artery infusion pump (HAIP) floxuridine-based chemotherapy plus standard systemic therapy and PDS01ADC, an investigational IL-12–based immunocytokine targeting necrotic tumor regions to enhance local immune activation. Cohorts are separated by tumor type.

ClinicalTrials.gov ID: NCT05286814