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Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant

Primary Purpose

Hepatocellular Carcinoma, Liver Transplant

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Camrelizumab plus apatinib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Camrelizumab, Apatinib, HCC, Liver transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-75 years
Pathology: hepatocellular carcinoma
Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL)
No interventional therapy (TACE, RFA or I131) within 2 month
Expected survival for more than 3 months
Child-pugh grade A or grade B (≤ 7 points)
Absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN
ECOG: 0-2
Patients participate in the study voluntarily and sign informed consent

Exclusion Criteria:

Regional lymph node metastases or extrahepatic metastases
Allergic to Camrelizumab or Apatinib
Patients who have had or are currently complicated with other malignant tumors
Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive)
Activ pulmonary tuberculosis or pulmonary tuberculosis history
Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma)
Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy
Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form of immunosuppressive therapy
Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)
Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment
Pregnant or lactating women
Patients who participated in other clinical trials within 1 month
Active infections which require systemic treatment
HIV positive
Other factors that may affect patients' safety or compliance

Sites / Locations

The First Affiliated Hospital of Medical School of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab plus apatinib

Arm Description

Outcomes

Primary Outcome Measures

Objective remission rate

The proportion of patients with CR, PR, and SD in the group

Recurrence-free survival

The period from enrollment surgery to recurrence of HCC

Secondary Outcome Measures

Overall survival

The survival rate in a year

Time to progress

The period from enrollment to disease progression

Adverse effect

Any adverse effects occur during the project

Full Information

NCT ID

NCT04035876

First Posted

July 20, 2019

Last Updated

July 26, 2019

Sponsor

Zhejiang University

Collaborators

Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04035876

Brief Title

Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant

Official Title

A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 16, 2019 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.

Detailed Description

HCC patients waiting for liver transplantation will be screened and enrolled according to the inclusion criteria. After screening and enrollment, patients will be administrated camrelizumab 200mg q2w iv and apatinib 250mg qd po regimen every 4 weeks as a cycle. Each patient will receive camrelizumab treatment for at least 2 cycles and discontinue camrelizumab 5 weeks before liver transplantation. Apatinib will be discontinued 1 week before liver transplantation. Once the tumor progression was detected, the program will be terminated and the appropriate optimal treatment will be given. The objective remission rate (ORR), recurrence-free survival (RFS), overall survival (OS), time to progress (TTP) and any adverse effect during the study will be evaluated in order to assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.

6. Conditions and Keywords

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

Hepatocellular Carcinoma, Liver Transplant

Keywords

Camrelizumab, Apatinib, HCC, Liver transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab plus apatinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Camrelizumab plus apatinib

Intervention Description

Camrelizumab 200mg q2w iv and apatinib 250mg qd po.

Primary Outcome Measure Information:

Title

Objective remission rate

Description

The proportion of patients with CR, PR, and SD in the group

Time Frame

From enrollment to disease progression, up to 6 months

Title

Recurrence-free survival

Description

The period from enrollment surgery to recurrence of HCC

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall survival

Description

The survival rate in a year

Time Frame

1 year

Title

Time to progress

Description

The period from enrollment to disease progression

Time Frame

From enrollment to disease progression, up to 6 months

Title

Adverse effect

Description

Any adverse effects occur during the project

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-75 years Pathology: hepatocellular carcinoma Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL) No interventional therapy (TACE, RFA or I131) within 2 month Expected survival for more than 3 months Child-pugh grade A or grade B (≤ 7 points) Absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN ECOG: 0-2 Patients participate in the study voluntarily and sign informed consent Exclusion Criteria: Regional lymph node metastases or extrahepatic metastases Allergic to Camrelizumab or Apatinib Patients who have had or are currently complicated with other malignant tumors Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive) Activ pulmonary tuberculosis or pulmonary tuberculosis history Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma) Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form of immunosuppressive therapy Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg) Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment Pregnant or lactating women Patients who participated in other clinical trials within 1 month Active infections which require systemic treatment HIV positive Other factors that may affect patients' safety or compliance

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianguo Wang, PhD

Phone

(+86)15967123327

21118059@zju.edu.cn

Facility Information:

Facility Name

The First Affiliated Hospital of Medical School of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianguo Wang, PhD

Phone

(+86)15967123327

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant

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