NCT04169399

Brief Summary

To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.

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
30

participants targeted

Target at P25-P50 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 17, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 17, 2019

Last Update Submit

November 17, 2019

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaToripalimabStereotactic body radiotherapyPortal vein tumor thrombus

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on iRECIST, or date of death, whichever occurred first

    6 months

Secondary Outcomes (3)

  • Overall survival (OS)

    6 months

  • Objective Response Rate (ORR)

    6 months

  • Adverse Events

    6 months

Study Arms (1)

Toripalimab plus SBRT

EXPERIMENTAL

Participants received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Participants recevied Stereotactic body radiotherapy. Radiotherapy dose was 36 \~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.

Drug: ToripalimabRadiation: Stereotactic body radiotherapy

Interventions

ToripalimabDRUG

240mg intravenously every 3 weeks

Toripalimab plus SBRT
Stereotactic body radiotherapyRADIATION

Radiotherapy dose was 36 \~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.

Toripalimab plus SBRT

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 mRECIST criteria
  • The normal liver volume in the non-target area was greater than 700ml
  • Portal vein tumor thrumbus confirmed in two image techniques
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • With no previous radiotherapy and immunotherapy
  • Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
  • The following laboratory parameters:
  • Platelet count ≥ 75,000/μL 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

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

toripalimabRadiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Ming Shi, MD

CONTACT

+862087343938shiming@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 17, 2019

First Posted

November 19, 2019

Study Start

November 17, 2019

Primary Completion

November 17, 2020

Study Completion

January 1, 2021

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

CN(1)