NCT04618367

Brief Summary

This study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and Sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

October 31, 2020

Last Update Submit

March 4, 2024

Conditions

Carcinoma, HepatocellularLiver NeoplasmsSintilimabPortal Vein Tumor Thrombus

Keywords

Carcinoma, HepatocellularlenvatinibSintilimabportal vein tumor thrombusoxaliplatin5-fluorouracilleucovorin

Outcome Measures

Primary Outcomes (1)

  • Progression free survival rate at 6 months

    Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause

    6 months

Secondary Outcomes (4)

  • Overall survival (OS)

    6 months

  • Progression free survival (PFS)

    6 months

  • Objective response rate (ORR)

    6 months

  • Adverse events

    6 months

Study Arms (1)

HAIC plus Lenvatinib and Sintilimab

EXPERIMENTAL

Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 200 mg intravenously every 3 weeks.

Procedure: Hepatic arterial infusion chemotherapyDrug: LenvatinibDrug: Sintilimab

Interventions

Hepatic arterial infusion chemotherapyPROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks

HAIC plus Lenvatinib and Sintilimab
LenvatinibDRUG

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

Also known as: TKI inhibits
HAIC plus Lenvatinib and Sintilimab
SintilimabDRUG

200mg intravenously every 3weeks

Also known as: programmed cell death protein-1 (PD-1) antibody
HAIC plus Lenvatinib and Sintilimab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. clinical diagnosis of HCC; 2. age between18 and 75 years; 3. refused to sorafenib treatment; 4. type I PVTT, type II PVTT, or type III PVTT. 5. Child-Pugh class A or B; 6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 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 8. Prothrombin time ≤18s or international normalized ratio \< 1.7. 9. Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

  • \. Diffuse HCC; 2. Extrahepatic metastasis; 3. Obstructive PVTT involving both the left and right portal vein or main portal vein.
  • \. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV 7. History of organ allograft 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • \. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

lenvatinibsintilimabAntibodies

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Kangshun Zhu, MD

    Second Affiliated Hospital of Guangzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 5, 2020

Study Start

January 1, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)