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Trial Title:
Radiotherapy + Sintilimab + Bevacizumab Biosimilar for uHCC With PVTT
NCT ID:
NCT05530785
Condition:
Hepatocellular Carcinoma Non-resectable
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
radiotherapy combined with sintilimab and bevacizumab biosimilar
Description:
After signing informed consent, patients received sintilimab 200 mg intravenously on the
first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered
intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose
3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between
the first administration of sintilimab and the second administration of bevacizumab, but
it should be noted that the interval between before and after the administration of
sintilimab and bevacizumab was at least 3 days.
Arm group label:
treatment group
Summary:
This study was a prospective, single-arm, single-center, phase II exploratory clinical
study. To investigate the efficacy and safety of radiotherapy combined with sintilimab
and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with
portal vein tumor thrombus.
Detailed description:
After signing informed consent, patients received sintilimab 200 mg intravenously on the
first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered
intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose
3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between
the first administration of sintilimab and the second administration of bevacizumab, but
it should be noted that the interval between before and after the administration of
sintilimab and bevacizumab was at least 3 days.
Patients will be performed enhanced CT/MRI every 2 months, to access the efficiency
according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1,
undergoing enhanced CT/MRI. The overall survival (OS) was calculated as the time from
enrollment until death or the last follow-up. Number of participants with
treatment-related adverse events as assessed by CTCAE v4.0 to access the safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Hepatocellular carcinoma confirmed by histology/cytology, or patients with cirrhosis
and meet the American Association for the Study of Liver Diseases (AASLD) clinical
diagnostic criteria for HCC
2. Child-pugh grade A or B (≤7 points)
3. A score of 0-1 according to the Eastern Cooperative Oncology Group Physical Status
Score (ECOG PS score);
4. Barcelona stage C; Inamicable for radical surgical resection or refusal of surgery
without extra-hepatic metastases; Portal vein tumor thrombus (PVTT) was diagnosed by
enhanced CT or enhanced MRI (type VP1 to VP3).
5. Had not received systemic therapy or radiotherapy before; Or disease progression
after surgical resection or local treatment (without radiotherapy);
6. At least one measurable or evaluable lesion according to the response evaluation
criteria for solid tumors, version 1.1 (RECIST V1.1); Or measurable lesions that had
clearly progressed after local treatment (based on RECIST V1.1 criteria).
7. Patients with liver lesions and/or portal vein tumor thrombus lesions were treated
with radiotherapy
Exclusion Criteria:
1. Previous histological/cytological diagnosis included fibrolamellar hepatocellular
carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other
components.
2. The area to be treated had been previously treated with radiotherapy
3. Patients with extrahepatic metastases
4. Patients with tumor thrombus invasion into the superior mesenteric vein
5. Patients with inferior vena cava tumor thrombus.
6. Central nervous system metastases were present.
7. A history of hepatic encephalopathy, or a history of liver transplantation.
8. There are clinical symptoms of pleural effusion, ascites, or pericardial effusion
that require drainage.
9. Patients with acute or chronic active hepatitis B or C with hepatitis B virus (HBV)
DNA>2000IU/ml or 10^4 Copies/ml; Hepatitis C virus (HCV)RNA> 10^3 Copies/ml;
Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were both positive.
10. History of allergy to active ingredients and/or excipients of anti-PD-1 mab and
anti-VEFG mab.
11. Other malignancies, except cured basal cell carcinoma of the skin and carcinoma in
situ of the cervix, were present within 5 years.
12. Bleeding events from esophageal or gastric fundus varices due to portal hypertension
had occurred within the previous 6 months. Severe (G3) varicose veins were known to
have been present on endoscopy within 3 months before the first dose. There was
evidence of portal hypertension (including splenomegaly on imaging) and a high risk
of bleeding as assessed by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Luo, Professor
Phone:
+86-0731-89762031
Email:
luojia@hnca.org.cn
Start date:
August 1, 2022
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Yongchang Zhang
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05530785
