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New trial matches liver cancer treatment to Tumor's Fat-Burning signature

NCT ID NCT07314372

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests a personalized approach for people with advanced liver cancer that cannot be removed by surgery. Researchers will classify each patient's tumor by its fatty acid degradation (FAD) subtype and assign either a drug combination (camrelizumab plus apatinib) or the same drugs plus a liver-directed procedure (TACE). The goal is to see if matching treatment to tumor metabolism improves response rates. The study plans to enroll 86 adults with unresectable hepatocellular carcinoma who have not had prior systemic therapy.

What this could mean

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

Active substance
camrelizumab plus apatinib, with or without TACE
What this could lead to
If successful, this could lead to a more effective, personalized treatment strategy for patients with advanced liver cancer that cannot be surgically removed.
What could go wrong
This is an early phase II trial with only 86 participants, so results may not apply to all patients. The treatment involves strong drugs and a procedure (TACE) that carry risks like bleeding or liver damage.

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

About 86 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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: 1. Adults ≥18 years of age who voluntarily agree to participate and sign informed consent. 2. Histologically or cytologically confirmed hepatocellular carcinoma (HCC). 3. Unresectable or not suitable for curative local therapy, or progression after prior surgery or local therapy. 4. BCLC stage B or C. 5. No prior systemic therapy for HCC. 6. At least one measurable lesion according to RECIST v1.1. 7. Availability of fresh or archival tumor tissue for FAD subtype testing; if not available at screening, MRI fat fraction may be used temporarily. 8. Child-Pugh class A or B (≤7 points). 9. ECOG performance status 0-1. 10. Adequate organ function, including: * ANC ≥1.5 × 10⁹/L * Platelets ≥75 × 10⁹/L * Hemoglobin ≥90 g/L * Albumin ≥30 g/L * Total bilirubin ≤1.5 × ULN * ALT and AST ≤3 × ULN * Serum creatinine ≤1.5 × ULN or creatinine clearance \>50 mL/min * INR ≤1.2 or PT within 2 seconds above ULN * Urine protein \<2+ or 24-hour urine protein \<1.0 g 11. Controlled HBV infection (HBV-DNA \<2000 IU/mL; if above this level, ≥1 week of antiviral therapy with ≥1-log reduction prior to first dose). HCV-positive individuals must be managed per clinical guidelines. 12. Life expectancy ≥12 weeks. 13. Women of childbearing potential must have a negative pregnancy test; participants of reproductive potential must agree to effective contraception during treatment and for 6 months afterward. Exclusion Criteria: 1. Non-HCC primary liver cancers (e.g., cholangiocarcinoma, combined HCC-CCA). 2. F3 subtype without liver lesions on imaging. 3. Clinically significant ascites requiring therapeutic intervention, or uncontrolled pleural/pericardial effusion. 4. Interstitial lung disease, pneumonitis requiring steroids, or active pulmonary infection. 5. Active or history of autoimmune disease requiring systemic treatment (exceptions allowed per protocol, e.g., controlled hypothyroidism). 6. Recent use (within 2 weeks) of systemic immunosuppressive therapy \>10 mg/day prednisone equivalent. 7. Gastrointestinal bleeding within 6 months, high-risk varices, active ulcers, fistula, perforation, or intra-abdominal abscess. 8. Known bleeding or clotting disorders; therapeutic anticoagulation not permitted. 9. Thromboembolic events within 6 months (e.g., stroke, PE). 10. Significant cardiovascular disease, including NYHA class ≥II heart failure, recent MI (within 1 year), unstable angina, clinically significant arrhythmias, or QTc prolongation. 11. Uncontrolled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite treatment), or history of hypertensive crisis. 12. Major vascular disease within 6 months (e.g., arterial thrombosis, aneurysm requiring repair). 13. Serious non-healing wounds, active ulcers, or fractures. 14. Inability to swallow oral medication or conditions affecting drug absorption. 15. Severe infection within 4 weeks, therapeutic antibiotics within 14 days, fever ≥38.5°C within 7 days before enrollment, or WBC \>15 × 10⁹/L. 16. Known HIV infection or other causes of immunodeficiency. 17. Receipt of live attenuated vaccines within 28 days before treatment. 18. Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results, including substance abuse, severe psychiatric illness, or social factors.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

More trials for these conditions

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