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Experimental drug combo aims to shrink inoperable liver tumors

NCT ID NCT05864105

Disease control Sponsor: Biotheus Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase II trial is testing whether a new biologic drug called PM8002, when combined with standard chemotherapy (FOLFOX), can shrink tumors in people with advanced liver cancer that cannot be removed by surgery. The study enrolls about 35 adults with inoperable hepatocellular carcinoma who have not received prior systemic therapy. Researchers will measure how many patients experience tumor shrinkage or disappearance.

What this could mean

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

Active substance
PM8002 (a biologic drug) plus FOLFOX chemotherapy (oxaliplatin, leucovorin, 5-fluorouracil)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with inoperable liver cancer, potentially shrinking tumors and improving outcomes.
What could go wrong
This is an early phase II study with only 35 participants, so results may not apply broadly. The combination may cause significant side effects, and the drug may not work as 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Apr 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. Male or female aged \>= 18 years; 3. HCC diagnosed by pathology or clinical; 4. BCLC stage C or B (unresectable or/and not suitable for local therapy); 5. Child-Pugh score \<= 7; 6. ECOG performance status of 0 or 1. Exclusion Criteria: 1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; 2. Symptomatic CNS metastases, not suitable for the study assessed by investigator; 3. Evidence of major coagulopathy or other obvious risk of bleeding; 4. Unable to accept enhanced imaging examination (CT or MRI) for any reason; 5. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 6. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome; 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Known history of alcohol abuse, psychotropic drug abuse or drug abuse; 9. Patients with psychiatric disorders or poor compliance; 10. Women who are pregnant or breastfeeding; 11. The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE; 12. Other conditions lead to inappropriate to participate in this study as judged by the investigator.

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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.

Hepatocellular carcinoma

Contacts and locations

Locations

  • Anhui Provincial Hospital

    Hefei, Anhui, China

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou, Zhejiang, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Jinhua Municipal Centeral Hospital Medical Group

    Jinhua, Zhejiang, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The First Hospital of Jilin University

    Changchun, Jilin, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, China

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