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SHR-1210 Plus Apatinib in Patients With Hepatocellular Carcinoma After Surgery

NCT ID: NCT03722875

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-03-01

Brief Summary

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SHR-1210 is a humanized anti-PD1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the efficacy and safety of adjuvant therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with Barcelona Clinic Liver Cancer (BCLC) B\&C stage hepatocellular carcinoma after surgery.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1210+ apatinib

SHR-1210 (200mg fixed dose every 3 weeks, one cycle is three weeks, total

1 year ) will be administered as an intravenous infusion over 30 minutes.

apatinib 250 mg qd ， one cycle is three weeks, total 1 year

Group Type EXPERIMENTAL

SHR-1210

Intervention Type DRUG

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

apatinib

Intervention Type DRUG

Apatinib is a selective VEGFR2 inhibitor

Interventions

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SHR-1210

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Intervention Type DRUG

apatinib

Apatinib is a selective VEGFR2 inhibitor

Intervention Type DRUG

Other Intervention Names

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Anti-PD-1 Antibody

Eligibility Criteria

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Inclusion Criteria

1. age:18-75 years, male or femal.
2. Hepatocellular carcinoma confirmed by histopathology, Child-Pugh A .
3. BCLC staging is stage B or C, preoperative assessment of no extrahepatic metastases.
4. ECOG Performance Status 0-1.
5. Alpha-fetoprotein (AFP) decreased to normal，3-4 weeks after surgery. If it is not normal, it must be checked that there is no clear lesion in MRI or CT.
6. Adequate organ function.
7. Patient has given written informed consent.

Exclusion Criteria

1. No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy and topical treatment, before surgery.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Tumors are not completely removed, or postoperative pathology suggests non-hepatocellular carcinoma or other malignant components;
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in- charge.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fan Jia, PHD

Role: CONTACT

Phone: 021 64041990/680774

Email: [email protected]

Facility Contacts

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Jia Fan

Role: primary

Other Identifiers

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ZSGY-PA-1809

Identifier Type: -

Identifier Source: org_study_id