Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

NCT ID: NCT05954897

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2027-01-01

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

Intervention Type: DRUG

RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab

Interventions

Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoming Chen

Role: PRINCIPAL_INVESTIGATOR

106 Second Zhongshan Road, Guangzhou, Guangdong

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Shi

Role: CONTACT

fengshihappy@126.com

+86 15989286619

Facility Contacts

Feng Shi

Role: primary

fengshihappy@126.com

+86 15989286619

Other Identifiers

KY2023-124-02

Identifier Type: -

Identifier Source: org_study_id