HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC

NCT03803254 | Withdrawn Phase 2 DMC

• 1 other identifier: HCC-S058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Lenvatinib; PD-1 Antibody; Oxaliplatin, 5-Fluorouracil and Leucovorin; Hepatic arterial infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

  12 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  12 months

• Objective Response Rate (ORR)

  12 months

• Adverse Events

  12 months

Study Arms (2)

HAIC plus lenvatinib and PD-1 antibody

EXPERIMENTAL

Hepatic arterial infusion chemotherapy plus lenvatinib and programmed cell death protein-1 antibody

Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol; Drug: Lenvatinib; Drug: PD-1 antibody

HAIC plus lenvatinib

ACTIVE COMPARATOR

Hepatic arterial infusion chemotherapy plus lenvatinib

Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol; Drug: Lenvatinib

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

HAIC plus lenvatinib; HAIC plus lenvatinib and PD-1 antibody

Folfox Protocol DRUG

Oxaliplatin , fluorouracil, and leucovorin

HAIC plus lenvatinib; HAIC plus lenvatinib and PD-1 antibody

Lenvatinib DRUG

12 mg (or 8 mg) once daily (QD) oral dosing.

HAIC plus lenvatinib; HAIC plus lenvatinib and PD-1 antibody

PD-1 antibody DRUG

3mg/kg intravenously every 2 weeks

HAIC plus lenvatinib and PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
• Barcelona clinic liver cancer-stage C
• Eastern Cooperative Oncology Group performance status of 0 to 2
• with no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:
• Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document

You may not qualify if:

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known central nervous system tumors including metastatic brain disease

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator

Study Sites (3)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, 510620, China

Location

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Folfox protocol; lenvatinib; spartalizumab

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

• Ming Shi, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 14, 2019
• Study Start: January 3, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 6, 2019

Record last verified: 2019-01

Locations

CN (3)