Combining radiotherapy with targeted therapy and immunotherapy for advanced liver cancer

A Study to Evaluate the Effects of Radiotherapy Combined With Tyrosine Kinase Inhibitor (TKI) and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)

This study is testing if combining radiotherapy with a targeted therapy and immunotherapy can help people with advanced liver cancer feel better and improve their treatment results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06061445 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of combining radiotherapy with a tyrosine kinase inhibitor (TKI) and an anti-PD-1 antibody for patients with Stage IIIA hepatocellular carcinoma that has developed portal vein tumor thrombus (PVTT). The study aims to enroll patients who meet specific diagnostic criteria and have not previously received systemic treatment. Participants will undergo a treatment regimen that includes these three modalities to assess their combined impact on tumor response and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with Stage IIIA hepatocellular carcinoma who are not eligible for surgical resection and have a good performance status.

Not a fit: Patients with liver cancer that is resectable or those who have previously received systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced liver cancer.

How similar studies have performed: While there is ongoing research in combining these therapies, the specific combination being tested in this trial is novel and has not been extensively studied together.

Eligibility criteria

Inclusion Criteria:

* Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard);
* Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable;
* CNLC was divided into stage IIIA, VP1-3 type;
* Child-Pugh classification of liver function is grade A (5-6 points);
* ECOG PS score 0-1;
* Expected survival ≥12 weeks;
* Patients with active hepatitis B virus (HBV) infection must be willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation;
* The major organs function normally and meet the following criteria :

  1. The blood routine examination criteria should meet :(no blood transfusion within 14 days)

     1. Hemoglobin (HB)≥90g/L,
     2. White blood cell count (WBC)≥3×109/L,
     3. Absolute neutrophil count (ANC)≥1.5×109/L,
     4. platelets (PLT)≥75×109/L;
  2. Biochemical examination should meet the following criteria:

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  1. Bilirubin (BIL)\< 1.5 times the upper limit of normal value (ULN);
  2. Alanine aminotransferase (ALT) and aspartate aminotransferase AST\<5ULN;
  3. Serum creatinine (Cr)≤1.5ULN
* Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the test drug; For males, they should be surgically sterilized or agree to use appropriate methods to avoid pregnancy during the trial and for 8 weeks after the last dose of the trial drug;
* The subjects voluntarily joined the study, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
* Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
* Patients with a history of epigastric radiotherapy;
* Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program;
* Patients who have participated in other clinical trials in the past three months;
* Previously received targeted therapy or other PD-1/PD-L1 inhibitor therapy;
* Received major surgery or chemotherapy, radiation therapy or other focal systemic therapy within 1 month before enrollment;
* Immunosuppressive agents or systemic hormone therapy (dose \>10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
* Liver function was classified as Child-Pugh C, which could not be improved by liver protection treatment.
* Esophageal (fundus) varices rupture and bleeding within 1 month before treatment.
* Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding. Platelet count \<50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy);
* Refractory ascites, bad fluid;
* Active infection, especially inflammation of the biliary system;
* Severe liver, kidney, heart, lung, brain and other major organ failure;
* People who have been allergic to any component of PD-1 monoclonal antibody or other similar experimental drugs;
* Have high blood pressure and can not be reduced to normal by antihypertensive medication

Where this trial is running

Fuzhou, Fujian

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Shaohua Xu, Master

Conditions Stage IIIA Hepatocellular Carcinoma