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

NCT05954897 | Recruiting Phase 2 DMC

• 1 other identifier: KY2023-124-02
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival

  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

• Overall survival

  Through study completion, up to 24 months

• Disease control rate

  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

• Adverse Events

  Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC

Interventions

Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• 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.
• Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
• 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.
• No prior treatment for HCC.
• At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
• Performance status (PS) ECOG score ≤1.
• Child-Pugh score ≤7.
• Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
• 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.

You may not qualify if:

• Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
• Previous liver transplantation;
• History of other malignancies;
• Previous history of severe mental illness;
• Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
• Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
• Other reasons were judged by the investigator to be unable to enroll.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xiaoming Chen

  106 Second Zhongshan Road, Guangzhou, Guangdong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Shi

CONTACT

+86 15989286619; fengshihappy@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)