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Trial Title:
Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)
NCT ID:
NCT06313190
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular carcinoma
Immunotherapy
Stereotactic body radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy
Description:
Patients in both cohorts will receive SBRT using volumetric arc therapy. The prescribed
dose is 30-54 Gy in 3 fractions over 1 week.
Arm group label:
Arm A
Arm group label:
Arm B
Other name:
SBRT
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Patients received sintilimab 200 mg every 3 weeks for up to 6 cycles, with the first dose
within 1 week after the completion of SBRT.
Arm group label:
Arm A
Other name:
IBI308
Summary:
For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy
(SBRT) is an effective and safe local treatment. Despite satisfactory local control rate,
the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9%
to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune
checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in
advanced HCC as well as resected high-risk HCC. Recently, the combination of
immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC
is unclear. The aim of this study was to investigate the efficacy and safety of SBRT
followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual
small HCC.
Detailed description:
A total of 140 patients with recurrent or residual small HCC will be stratified according
to tumor diameter (≤3 vs. >3 cm) and tumor type (recurrent vs. residual) and randomly
assigned (1:1) to receive stereotactic body radiotherapy (SBRT) with or without adjuvant
sintilimab for 6 cycles (200 mg, once every 3 weeks, with the first dose within 1 week
after the completion of SBRT).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Contact:
Last name:
Mian Xi, MD
Phone:
+862087343385
Email:
ximian@sysucc.org.cn
Investigator:
Last name:
Mian Xi, MD
Email:
Principal Investigator
Investigator:
Last name:
Qi Zeng, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yi Lu, MD
Email:
Sub-Investigator
Start date:
April 5, 2024
Completion date:
April 30, 2030
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Ningbo Medical Center Lihuili Eastern Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313190