Combining radiation therapy and immunotherapy for small liver cancer

Stereotactic Body Radiotherapy With or Without Adjuvant Immunotherapy for Small Hepatocellular Carcinoma: An Open-label, Randomized, Phase II Trial

This study is testing if combining a type of radiation therapy with an immunotherapy drug can help people with small liver cancer do better and have fewer recurrences.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, sintilimab, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06313190 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of combining stereotactic body radiotherapy (SBRT) with the immunotherapy drug sintilimab in patients with recurrent or residual small hepatocellular carcinoma (HCC). A total of 140 patients will be enrolled and randomly assigned to receive either SBRT alone or SBRT followed by sintilimab for six cycles. The patients will be stratified based on tumor size and type to assess the treatment's efficacy. The goal is to improve the local control of HCC and reduce recurrence rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or residual small HCC lesions that meet specific criteria.

Not a fit: Patients with vascular invasion, extrahepatic metastasis, or those with Child-Pugh class B or C liver function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with small hepatocellular carcinoma.

How similar studies have performed: Previous studies have shown promising results with the combination of immunotherapy and SBRT in HCC, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed hepatocellular carcinoma or diagnosed by American Association for the Study of Liver Disease criteria;
2. Presence of recurrent or residual HCC lesions without vascular invasion or extrahepatic metastasis confirmed by CT or MRI, the sum of the maximum diameter of lesions ≤5 cm, total number of lesions were ≤2, and at least one of which is measurable according to the RECIST 1.1 Criteria;
3. Previous molecular targeted therapy or intravenous chemotherapy is allowed, but the interval of drug withdrawal was at least 6 months prior to protocol therapy;
4. Age at diagnosis 18 to 75 years;
5. Eastern Cooperative Oncology Group performance status ≤ 2
6. Child-Pugh class A liver function;
7. Normal liver volume greater than 700 ml;
8. Estimated life expectancy ≥24 weeks;
9. The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 50×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min;
10. Ability to understand the study and sign informed consent.

Exclusion Criteria:

1. Patients who have previously been treated with immune checkpoint inhibitors;
2. Patients with extrahepatic metastasis disease;
3. A history of abdominal radiotherapy;
4. Known or suspected allergy or hypersensitivity to monoclonal antibodies;
5. Patients who have a preexisting or coexisting bleeding disorder;
6. Female patients who are pregnant or lactating;
7. Inability to provide informed consent due to psychological, familial, social and other factors;
8. A history of malignancies other than hepatocellular carcinoma before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
9. A history of diabetes for more than 10 years and poorly controlled blood glucose levels;
10. Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
11. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;
12. A history of interstitial lung disease or non-infectious pneumonia;
13. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
15. Any unstable situation that may endanger the safety and compliance of patients.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Mian Xi, MD — Sun Yat-Sen University Cancer Center
• Study coordinator: Mian Xi, MD

Conditions: Hepatocellular Carcinoma, Hepatocellular carcinoma, Immunotherapy, Stereotactic body radiotherapy