NCT04042805

Brief Summary

This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.

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
36

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2019

Longer than P75 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

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

July 30, 2019

Last Update Submit

February 27, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    1 year after the last patient's enrollment

Secondary Outcomes (4)

  • Overall Survival

    2 years after the last patient's enrollment

  • Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).

    2 years after the last patient's enrollment

  • Conversion rate to surgery

    1 year after the last patient's enrollment

  • Tumor mutation burden in association with ORR and survival.

    1 year after the last patient's enrollment

Study Arms (1)

Sintilimab Plus Lenvatinib

EXPERIMENTAL

Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Biological: SintilimabDrug: Lenvatinib

Interventions

SintilimabBIOLOGICAL

200mg intravenously every 3 weeks

Also known as: IBI308
Sintilimab Plus Lenvatinib
LenvatinibDRUG

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

Sintilimab Plus Lenvatinib

Eligibility Criteria

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

You may qualify if:

  • Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
  • Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
  • No previous systemic anticancer treatment or TACE treatment
  • Age ≥18 years
  • ECOG performance status: 0-1
  • Child Pugh score≤7
  • Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
  • Life expectancy ≥12 weeks.
  • Patients must be able to understand and willing to sign a written informed consent document

You may not qualify if:

  • Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
  • History of hepatic encephalopathy or liver transplantation
  • Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
  • Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity
  • 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
  • Pregnant women, nursing mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimablenvatinib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Baocai Xing, Doctor

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baocai Xing, Doctor

CONTACT

+8613910721238xingbaocai88@sina.com

Study Design

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

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 2, 2019

Study Start

August 1, 2019

Primary Completion

August 30, 2022

Study Completion

August 30, 2024

Last Updated

March 2, 2021

Record last verified: 2021-02

Locations

CN(1)