Clinical Trials for Liver Cancer

PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver 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: Enrolls adults with biopsy-proven NSCLC (excluding EGFR/ALK/ROS1/RET-altered tumors) or melanoma with radiographic liver metastases, ECOG 0–2, eligible for standard PD-1/PD-L1 checkpoint inhibitor–based therapy (± chemotherapy and/or CTLA-4 inhibition per routine practice). All patients receive standard systemic therapy plus investigational low-dose liver radiation delivered in the week before cycles 1, 2, and 3 to potentially modulate the hepatic immune microenvironment and enhance checkpoint inhibitor efficacy.

ClinicalTrials.gov ID: NCT07225036

Phase 1, Single-site, Single-arm, Clinical Imaging, and Blood-based Biomarker Trial Utilizing 18F-FSPG PET to Guide Therapy in 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.

TrialFetch AI summary: Adults (≥18) with imaging- or pathology-confirmed hepatocellular carcinoma meeting LI-RADS criteria who are candidates for Y90 radioembolization monotherapy. Patients receive standard Y90, with investigational 18F-FSPG PET/CT (a glutamate analog tracer reflecting system xC−/redox-related amino acid transport activity) plus paired ctDNA blood sampling before and after treatment to assess early prediction/detection of response or resistance versus standard imaging over 12 months.

ClinicalTrials.gov ID: NCT07116486

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

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 resectable, liver-confined colorectal cancer metastases (≥1 lesion ≥2 cm) scheduled for standard hepatectomy undergo percutaneous implantation of an intratumoral microdevice into a liver metastasis 3–5 days pre-op, with en bloc retrieval at surgery. The device locally releases microdoses of multiple anticancer agents (e.g., FOLFOX/FOLFIRI/FOLFIRINOX components, bevacizumab, doxorubicin, and immunotherapies including botensilimab [Fc-enhanced anti–CTLA-4], balstilimab [anti–PD-1], and AGEN2373) to assess tissue-level drug diffusion and pharmacodynamic response, focusing on procedural safety/feasibility rather than systemic treatment.

ClinicalTrials.gov ID: NCT07193862

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