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Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Lenvatinib
Sponsored by
Baocai Xing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sintilimab Plus Lenvatinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Overall Survival
Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).
Conversion rate to surgery
Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment
Tumor mutation burden in association with ORR and survival.
It will be performed by NGS.

Full Information

First Posted
July 30, 2019
Last Updated
February 27, 2021
Sponsor
Baocai Xing
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1. Study Identification

Unique Protocol Identification Number
NCT04042805
Brief Title
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
Official Title
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Baocai Xing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab Plus Lenvatinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI308
Intervention Description
200mg intravenously every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
12 mg (or 8 mg) once daily (QD) oral dosing.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
1 year after the last patient's enrollment
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
2 years after the last patient's enrollment
Title
Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).
Time Frame
2 years after the last patient's enrollment
Title
Conversion rate to surgery
Description
Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment
Time Frame
1 year after the last patient's enrollment
Title
Tumor mutation burden in association with ORR and survival.
Description
It will be performed by NGS.
Time Frame
1 year after the last patient's enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baocai Xing, Doctor
Phone
+8613910721238
Email
xingbaocai88@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baocai Xing, Doctor
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Wang, Doctor
Phone
+8615801154770
Email
wanglijun1017@163.com
First Name & Middle Initial & Last Name & Degree
Baocai Xing, Doctor

12. IPD Sharing Statement

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Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

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