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Trial Title:
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma
NCT ID:
NCT05954897
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
Description:
RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and
Tislelizumab
Arm group label:
Experimental group
Summary:
To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX
regimen HAIC in advanced hepatocellular carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18 years or older.
2. HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary
Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases
(AASLD) criteria.
3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging
system.
4. A dominant mass in theliver with or without extrahepatic oligometastasis, which was
defined as up to three metastatic lesions in up to two organs with the largest
diameter of≤3 cm.
5. No prior treatment for HCC.
6. At least one measurable target lesion according to modified Response Evaluation
Criteria in Solid Tumors (mRECIST).
7. Performance status (PS) ECOG score ≤1.
8. Child-Pugh score ≤7.
9. Subjects voluntarily participate in this study, and sign the informed consent form,
cooperate with the follow-up
10. Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 ^ 9/L; PLT ≥ 75 x
10 ^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3
times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times
the upper limit of normal.
Exclusion Criteria:
1. Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC,
hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
2. Previous liver transplantation;
3. History of other malignancies;
4. Previous history of severe mental illness;
5. Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural
effusion or pericardial effusion;
6. Active bleeding or coagulation abnormalities, bleeding tendency or receiving
thrombolytic, anticoagulant or antiplatelet therapy;
7. Other reasons were judged by the investigator to be unable to enroll.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Shi
Phone:
+86 15989286619
Email:
fengshihappy@126.com
Start date:
September 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954897
