New cocktail therapy aims to shrink advanced liver tumors
NCT ID NCT07062055
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests a new treatment plan for people with advanced liver cancer that has spread to blood vessels or a few other spots. The plan combines chemotherapy directly into the liver, two immunotherapy drugs, a targeted therapy, and precise radiation. The goal is to see if this approach can slow the cancer's growth and improve quality of life. About 54 adults with good liver function are being enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged between 18 and 70 years. 2. Unresectable HCC, BCLC Stage C according to the BCLC strategy-2026 update, with staging established via biopsy pathology and/or clinical diagnosis. 3. Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Metastatic burden and local therapy eligibility * Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions * All intended intrahepatic and/or extrahepatic SBRT targets must satisfy protocol-specified target-coverage, liver reserve, and organ-at-risk (OAR) constraints within a composite 5-fraction plan 5. Prognosis \& measurable disease * Life expectancy ≥3 months * ≥1 measurable lesion (per RECIST 1.1): * Tumor: ≥10 mm (CT long axis) * Lymph node: ≥15 mm (CT short axis) 6. Prior therapy * Prior locoregional therapy permitted:radiofrequency ablation (RFA), TACE, or HAIC, provided that: * Documented radiographic progression or intolerance after the prior therapy * Washout ≥28 days * Treatment-related toxicities recovered to ≤Grade 1 (alopecia and peripheral neuropathy ≤Grade 2 allowed) 7. Laboratory and virologic requirements * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN); total bilirubin \<3 × ULN; serum albumin ≥28 g/L * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min * Urine dipstick protein \<2+; if baseline dipstick proteinuria is ≥2+, 24-hour urinary protein must be \<1 g * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN Exclusion Criteria: 1. Histopathological exclusions * Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components 2. Curative local therapy candidacy * Current candidacy for resection, liver transplant, or RFA 3. RT infeasibility * Prior radioembolization * Single liver tumor ≥15 cm or total intrahepatic tumor diameter ≥20 cm * more than 5 discrete intrahepatic parenchymal foci are present * direct tumor extension into the stomach, duodenum, small bowel, or large bowel * measurable common or main-branch biliary duct involvement * Prior liver radiotherapy that would result in excessive overlap with the planned treatment fields 4. Prior systemic therapies * Received targeted-immunotherapy for HCC (e.g., PD-(L)1 inhibitors + tyrosine kinase inhibitors (TKIs)) * Prior immunotherapy: anti-PD-(L)1/CTLA-4 or chimeric antigen receptor T-cell therapy 5. Hemorrhage/portal hypertension and hepatic decompensation risk * Variceal bleeding within 6 months. * Untreated or high-risk esophagogastric varices (e.g., grade ≥2 on endoscopy within 3 months) or other clinical evidence of portal hypertension with high bleeding risk per investigator. * Moderate or severe ascites * History of or active hepatic encephalopathy * History of hemoptysis (≥2.5 mL of bright red blood per episode) within 28 days before study treatment * Evidence of bleeding diathesis or significant coagulopathy * Current or recent (within 10 days before study treatment) use of aspirin (≥325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, or therapeutic-dose oral/parenteral anticoagulants or thrombolytic agents 6. Allergy to any component of iparomlimab/tuvonralimab or bevacizumab 7. Comorbidities * Active autoimmune disease or a history of autoimmune or inflammatory disease that may relapse; exceptions include hypothyroidism controlled with hormone replacement only, controlled celiac disease, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) * Any condition requiring systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days before study treatment * Active or uncontrolled infection, including tuberculosis, or known HIV infection * Prior allogeneic stem cell transplantation or organ transplantation * Inadequately controlled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure \>90 mmHg despite optimal medical management, or a history of hypertensive crisis or hypertensive encephalopathy * History within 6 months before study treatment of myocardial infarction, unstable angina, symptomatic heart failure (New York Heart Association class ≥II), cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events * Major surgical procedure within 28 days before study treatment, or serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture * History within 6 months before study treatment of gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shandong Cancer Hospital and Institute
RECRUITINGJinan, Shandong, China
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Other studies related to the condition(s) this trial covers.
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- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial
- Radiation plus targeted antibody tested in older head and neck cancer patients