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Can a Four-Drug cocktail tame inoperable liver cancer?

NCT ID NCT07746960

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.