Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Combining surgery with targeted and immunotherapy for advanced liver cancer

Official title: Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma

Run by Tongji Hospital · NCT06470256 · Data updated 2026-11-12

This study is testing whether combining surgery with targeted therapy and immunotherapy can help people with advanced liver cancer live longer and feel better.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment50 (estimated)
SponsorTongji Hospital
Academic / other
Drugs / interventionsimmunotherapy, Durvalumab, Lenvatinib, radiation
Locations1 site (Wuhan, Hubei)
StatusRecruiting
StartedJune 1, 2024
Main results expectedJune 1, 2027
Study endsJune 1, 2028
Registry record updatedJune 24, 2024
Trial IDNCT06470256 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with advanced hepatocellular carcinoma who have not received prior systemic treatment and meet specific tumor burden criteria.

Probably not a fit

Patients with early-stage HCC or those who have already undergone systemic antitumor treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of palliative hepatectomy combined with targeted therapy and immunotherapy for patients with advanced hepatocellular carcinoma (HCC). It is a prospective, multicenter, single-arm study that aims to evaluate whether this combined approach can improve treatment outcomes and prolong survival in patients who are not candidates for curative surgery. Participants will receive a combination of local treatments and medications, followed by surgery if their disease is stable or progressing after three months of treatment. The study focuses on patients with significant tumor burden who may benefit from reducing their tumor size through this innovative approach.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that improves survival rates for patients with advanced HCC.

How similar studies have gone: While palliative hepatectomy has been explored in other malignancies, this specific combination of therapies for advanced HCC is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients aged 18 to 75 years (inclusive).
2. No prior systemic antitumor treatment or surgical treatment.
3. Clinical or pathological diagnosis of hepatocellular carcinoma (HCC).
4. The primary liver lesion is mainly isolated liver tumors, with a tumor burden exceeding 90% of the total tumor burden, and technically capable of complete resection. Simultaneously merging ① intrahepatic metastasis: the number of metastatic tumors is ≥ 3 and the sum of tumor diameters is ≤ 3cm; Or ② Extrahepatic metastasis: Extrahepatic metastasis does not exceed one organ, metastatic tumors do not exceed three, and the total diameter does not exceed 3cm. Or ③ if combined with portal vein tumor thrombus or hepatic vein tumor thrombus, it can be removed or completely removed together with the main tumor, and the tumor thrombus does not enter the superior mesenteric vein or inferior vena cava.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, without significant organ dysfunction.
6. Child-Pugh class A.
7. HBV-DNA less than 1\*10\^5 copies/ml and undergoing antiviral therapy.
8. Important organ functions meeting the following criteria: White Blood Cell (WBC) ≥2.5 × 10\^9/L ;Platelet (PLT) ≥75 × 10\^9/L;Hemoglobin (HB) ≥ 9g/dL;Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3\*ULN, Total Bilirubin ≤ 3\*ULN; International Normalized Ratio (INR) ≤ 1.5\*ULN; Prothrombin Time ≤ 1.5\*ULN; Creatinine ≤ 1.5\*ULN.
9. Expected survival time of more than 3 months.
10. According to the RECIST v1.1 standard, postoperative patients with at least one longest diameter of 1 cm or more measurable tumors.
11. Willing to provide informed consent.

Exclusion Criteria:

1. History of or concurrent active malignancy (excluding malignancies that have been cured for over 5 years or in situ cancers that can be completely cured with adequate treatment).
2. Presence of central nervous system metastasis or a history of brain metastasis.
3. History of organ transplantation.
4. History of surgery in the head, chest, or abdomen within the past six months.
5. Child-Pugh class C liver function or massive ascites.
6. Ongoing active infection within 7 days after completion of systemic antibiotic therapy.
7. Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within the past 12 months before enrollment.
8. Thrombotic or embolic events within the past 12 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis.
9. New York Heart Association (NYHA) class II or above congestive heart failure.
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), positive syphilis serology, untreated active hepatitis (defined as HBV-DNA ≥ 10\^5 copies/ml; HCV-RNA higher than the lower limit of detection for the assay).
11. Any active, known, or suspected autoimmune disease. Stable subjects not requiring systemic immunosuppressive therapy may be included, such as those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).
12. Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
13. Pregnant or lactating women or females with a positive pregnancy test prior to the first dose who have the potential for pregnancy.
14. The investigator deems the subject inappropriate for participation in this clinical study due to any clinical or laboratory abnormalities or compliance issues.
15. Severe psychological or mental abnormalities.
16. Participation in another drug clinical trial within the past 4 weeks.
17. Other reasons that the investigator considers unsuitable for enrollment.

Where it's running

  • Tongji Hospital
    Wuhan, Hubei, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.