NCT04170179

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with hepatocellular carcinoma with extrahepatic metastasis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

November 18, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

November 18, 2019

Last Update Submit

February 19, 2021

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaLenvatinibToripalimabSystemic chemotherapyOxaliplatin, leucovorin, 5-fluorouracilExtrahepatic metastasis

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)

Systemic chemotherapy plus lenvatinib and toripalimab

EXPERIMENTAL

Systemic chemotherapy of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 240mg intravenously every 3 weeks.

Procedure: Systemic chemotherapyDrug: LenvatinibDrug: Toripalimab

Interventions

Systemic chemotherapyPROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the peripherally inserted central catheter every 3 weeks

Systemic chemotherapy plus lenvatinib and toripalimab
LenvatinibDRUG

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

Systemic chemotherapy plus lenvatinib and toripalimab
ToripalimabDRUG

240mg intravenously every 3 weeks

Systemic chemotherapy plus lenvatinib and toripalimab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Presence of extrahepatic metastasis
  • 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

You may not qualify if:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • History of immunotherapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Neoadjuvant Therapylenvatinibtoripalimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Ming Shi, MD

CONTACT

+862087343938shiming@sysucc.org.cn

QiJiong Li, MD

CONTACT

+862087343938liqj@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

November 19, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

CN(1)