Clinical Trials for Liver Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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, non-curable HCC and Child-Pugh B7 cirrhosis after 1–2 prior systemic therapies (ECOG 0–1) are randomized 2:1 to oral namodenoson 25 mg BID versus placebo. Namodenoson is a selective adenosine A3 receptor agonist targeting tumor/inflamed liver A3AR with downstream PI3K/AKT, NF-κB, and Wnt/β-catenin modulation; prior phase II suggested a survival signal in CP-B7 with favorable tolerability.

ClinicalTrials.gov ID: NCT05201404

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089

A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

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.

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with well-differentiated, locally advanced/metastatic NETs and symptomatic carcinoid syndrome (≥1 daily flushing episode; SRL-naïve or washed out, without recent progression or confounding diarrhea causes) are randomized to oral paltusotine 80 mg daily vs placebo. Paltusotine is an investigational selective SST2 agonist intended to suppress serotonin-mediated symptoms (flushing/diarrhea), with open-label paltusotine available after the blinded period.

ClinicalTrials.gov ID: NCT07087054

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

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 hepatobiliary cancers: HCC cohorts receive volrustomig (PD-1/CTLA-4 bispecific) or rilvegostomig (PD-1/TIGIT bispecific) as monotherapy or combined with bevacizumab or lenvatinib, including a triple-immunotherapy/bevacizumab arm; BTC cohort (first-line) receives volrustomig or rilvegostomig with gemcitabine/cisplatin. Aims to assess response/PFS and safety of dual-checkpoint bispecifics, leveraging PD-1–anchored CTLA-4 or TIGIT blockade to enhance intratumoral T-cell activity.

ClinicalTrials.gov ID: NCT05775159

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 advanced or metastatic solid tumors—including SCLC, NSCLC, ESCC, CRPC, melanoma, HCC, cervical cancer, HNSCC, and select rare cancers—who have progressed after or are intolerant to standard therapies. Patients receive DB-1311, an anti-B7-H3 antibody-drug conjugate linked to a topoisomerase I inhibitor, administered intravenously every 3 weeks.

ClinicalTrials.gov ID: NCT05914116

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 advanced or metastatic solid tumors that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Single-arm study of oral memantine, a noncompetitive NMDA receptor antagonist, as monotherapy for adults with unresectable, locally advanced or metastatic HCC and decompensated liver function (Child-Pugh ≥ B7), ECOG 0–2, who are not candidates for intensive systemic therapy. Includes previously untreated patients with measurable disease; key exclusions include Child-Pugh A, rare HCC variants, significant recent CV events, and active CNS metastases.

ClinicalTrials.gov ID: NCT06007846

A Phase Ib Study of Cryoablation and Pressure-enabled Hepatic Arterial Infusion of Class C Toll-like Receptor 9 Agonist SD-101 in Combination with Durvalumab and Tremelimumab in Patients with Advanced Hepatocellular Carcinoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Adults with locally advanced/metastatic or unresectable HCC, systemic-therapy–naive for advanced disease (ECOG 0–1, Child-Pugh A–B7), undergo focal hepatic lesion cryoablation plus pressure-enabled hepatic arterial infusion of SD-101 (nelitolimod, a class C TLR9 agonist activating pDCs/type I IFN signaling) followed 7–10 days later by STRIDE: one priming dose of tremelimumab and durvalumab every 4 weeks. Requires at least one hepatic lesion ≥3 cm away from critical structures; excludes active autoimmune disease requiring immunosuppression, uncontrolled comorbidities, and active CNS disease.

ClinicalTrials.gov ID: NCT06710223

A Phase I/II Trial of Sapanisertib in Combination With Cabozantinib in β-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Adults with advanced/metastatic hepatocellular carcinoma, enriched for β‑catenin (CTNNB1)–mutated disease (Phase II requires CLIA-confirmed mutation, Child-Pugh A, ECOG 0–2, prior ICI), randomized to cabozantinib alone vs cabozantinib plus sapanisertib (TAK‑228), an oral ATP-competitive mTORC1/2 inhibitor. Allows controlled HBV/HCV and treated/stable brain mets; excludes prior cabozantinib and strong CYP3A4 inhibitors.

ClinicalTrials.gov ID: NCT06811116

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

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 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