Combining surgery with targeted and immunotherapy for advanced liver cancer

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

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

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: immunotherapy, Durvalumab, Lenvatinib, radiation
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06470256 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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 performed: 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.

Eligibility 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 this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Zhiyong Huang — Tongji Hospital
• Study coordinator: Zhiyong Huang

Conditions: Advanced Hepatocellular Carcinoma, HCC, Palliative Hepatectomy, Immunotherapy, Targeted therapy