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New hope for advanced liver cancer: experimental drug takes on standard therapy

NCT ID NCT07300488

Disease control Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new drug, pracytarabine, to the standard drug regorafenib in 60 people with advanced liver cancer that has stopped responding to targeted therapy and immunotherapy. The goal is to see if pracytarabine can help patients live longer. Participants receive either drug by infusion or pill, and researchers track survival and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pracytarabine
What this could lead to
If it works, this could offer a new treatment option for people with advanced liver cancer who have run out of standard therapies.
What could go wrong
This is an early-to-mid-stage trial with only 60 participants, so results may not apply widely. The new drug may not work better or could have unexpected side effects.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

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

Started

Sep 2025

Expected to finish

Apr 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 to 75 years

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: 1. Aged 18-75 years, regardless of gender. 2. Diagnosed with HCC either by histopathological and/or cytological examination meeting pathological diagnostic criteria, or in line with the clinical diagnostic criteria of the aforementioned guidelines. 3. Unresectable or metastatic HCC, and have experienced treatment failure with targeted drugs and immune checkpoint inhibitors. 4. Child-Pugh liver function score: Class A/B (≤7 points). 5. Expected survival time ≥ 3 months. 6. ECOG performance status 0 or 1. 7. Barcelona Clinic Liver Cancer (BCLC) stage B or C. 8. No severe involvement of the portal vein, and no invasion of the hepatic vein, superior vena cava, or inferior vena cava. Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 2. Previous history of liver or other organ transplantation. 3. Has participated in another clinical study within 4 weeks prior to the first dose. 4. Has a known history of, or any evidence of CNS metastases. 5. Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites. 6. History of bleeding event due to esophageal and/or gastric varices within 3 months prior to the first dose of study treatment.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCC

Contacts and locations

Locations

  • Nanjing Tianyinshan Hospital

    Nanjing, Jiangsu, 211100, China

More trials for these conditions

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