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Can a Four-Drug cocktail tame inoperable liver cancer?
NCT ID NCT07746960
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial is testing whether a combination of chemotherapy, immunotherapy, and a targeted therapy can help people with unresectable hepatocellular carcinoma, a type of liver cancer that cannot be removed with surgery. Participants receive a regimen of two chemotherapy drugs (oxaliplatin and raltitrexed) plus an immunotherapy drug (penpulimab) and an oral targeted therapy (anlotinib). The study aims to see how well this combination shrinks tumors and how safe it is for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of intravenous chemotherapy (oxaliplatin and raltitrexed), an immunotherapy drug (penpulimab), and an oral targeted therapy (anlotinib)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with liver cancer that cannot be removed by surgery, potentially shrinking tumors and extending life.
- What could go wrong
- This is an early-stage, small trial, so the benefits are uncertain. The combination may cause significant side effects, and the response rate could be lower than hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2027
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 years and older
- 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: * Adult males or females; * Meeting the relevant criteria in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)", and diagnosed with HCC through examinations such as ultrasound, enhanced CT and, magnetic resonance imaging, liver puncture biopsy; * Patients with unresectable HCC (patients with recurrence after radical resection are eligible for enrollment); * ECOG PS score ≤ 2; * Liver function of Child-Pugh class A/B, and liver function reserve ICG ≤ 30%; * According to the mRECIST criteria for tumor assessment, having ≥ 1 measurable intrahepatic target lesion, and the estimated survival period ≥ 6 months; * Normal organ and bone marrow functions before randomization, including: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.0 × 10\^9/L, platelet count ≥ 75 × 10\^9/L, total bilirubin ≤ 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN, albumin ≥ 28 g/L, international normalized ratio PT-INR ≤ 1.6, glomerular filtration rate (DCK-EPI formula) ≥ 50 mL/min, urine protein \< 2+ or 24 - hour urine protein quantification \< 1.0 g; * Those who voluntarily sign the informed consent form. Exclusion Criteria: * Patients with obvious abnormalities in organ and bone marrow functions that are difficult to reverse before randomization, including: hemoglobin \< 90 g/L, absolute neutrophil count \< 1.0 × 10\^9/L, platelet count \< 75 × 10\^9/L, total bilirubin \> 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 5 × ULN, albumin \< 28 g/L, international normalized ratio PT - INR \> 1.6, glomerular filtration rate (CKD - EPI formula) \< 30 mL/min, urine protein ≥ 2+ or 24 - hour urine protein quantification ≥ 1.0 g. * Patients with infection, bleeding tendency, massive ascites and hepatic encephalopathy. * Patients who have been using hepatotoxic drugs for a long - term due to their own diseases and cannot stop taking the drugs. * Patients who have previously received chemotherapy, radiotherapy, immunotherapy or targeted therapy. * Patients with other severe diseases of the heart, brain, kidneys and other organs, autoimmune diseases, or diseases such as HIV/tuberculosis that the researcher deems inappropriate for enrollment. * Patients who fail to complete the treatment cycle before tumor assessment after the first treatment. * Patients with incomplete clinical general data or imaging data. * Patients who are currently participating in other therapeutic studies.
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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.
Contacts and locations
Locations
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New combo therapy aims to stop liver cancer in its tracks
- New combo therapy aims to shrink liver tumors in Hard-to-Treat patients