Clinical trial NCT05954897: Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma
Official title: Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.


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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 12 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
measure: Overall survival
timeFrame: Through study completion, up to 24 months
measure: Disease control rate
timeFrame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
measure: Adverse Events
timeFrame: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: 106 Second Zhongshan Road, Guangzhou, Guangdong
name: Xiaoming Chen
role: PRINCIPAL_INVESTIGATOR
References: