NCT04104074

Brief Summary

The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.

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
20

participants targeted

Target at P25-P50 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_1 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

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 25, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

September 24, 2019

Last Update Submit

July 5, 2020

Conditions

Hepatocellular CarcinomaPortal Vein Tumor Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events

    Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria

    1 year

Secondary Outcomes (3)

  • Overall response rate (ORR)

    1 year

  • Progression-free survival (PFS)

    2 years

  • Overall Survival (OS)

    2 years

Study Arms (1)

Radiotherapy Plus Sintilimab

EXPERIMENTAL

HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.

Radiation: RadiotherapyDrug: Sintilimab

Interventions

RadiotherapyRADIATION

Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy. Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.

Radiotherapy Plus Sintilimab
SintilimabDRUG

Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks

Also known as: IBI308
Radiotherapy Plus Sintilimab

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and willingness to sign a written informed consent document.
  • Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
  • Has at least 1 measurable lesion
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate organ function
  • Child Pugh class A
  • Life expectancy ≥12 weeks.
  • Antiviral therapy per local standard of care for hepatitis B
  • Woman of child bearing potential must have a negative pregnancy test
  • Must use acceptable form of birth control while on study

You may not qualify if:

  • Has previously been performed by raditotherapy for the area to be treated.
  • With extrahepatic metastasis
  • History of hepatic encephalopathy or liver transplantation
  • Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive
  • Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
  • Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment
  • With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable
  • Evidence of active pulmonary tuberculosis (TB)
  • Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
  • History of allergic reactions to related drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiotherapysintilimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gong Li, MD

    Beijing Tsinghua Changgeng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gong Li, MD

CONTACT

0086-10-56119427dr_gongli@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

November 25, 2019

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

CN(1)