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

Hepatocellular Carcinoma Clinical Trial

Official title:

Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954897
• Other study ID #: KY2023-124-02
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: July 2023
• Source: Guangdong Provincial People's Hospital
• Contact: Feng Shi
• Phone: +86 15989286619
• Email: fengshihappy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR) under mRECIST criteria	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	Progression-free survival	The date from the date of admission to the date of the first progression of disease or death of any cause.	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
Secondary	Overall survival	The date from the date of admission to the date of death of any cause	Through study completion, up to 24 months
Secondary	Disease control rate	The percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy	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
Secondary	Adverse Events	Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.	Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).