New trial matches liver cancer treatment to Tumor's Fat-Burning signature
NCT ID NCT07314372
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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: 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
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