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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04035876
• Other study ID #: KY2019-SHR-APA-ZJU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 16, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: Zhejiang University
• Contact: Jianguo Wang, PhD
• Phone: (+86)15967123327
• Email: 21118059[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplant

Intervention

Drug:
• Camrelizumab plus apatinib
Camrelizumab 200mg q2w iv and apatinib 250mg qd po.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang

Sponsors (9)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective remission rate	The proportion of patients with CR, PR, and SD in the group	From enrollment to disease progression, up to 6 months
Primary	Recurrence-free survival	The period from enrollment surgery to recurrence of HCC	1 year
Secondary	Overall survival	The survival rate in a year	1 year
Secondary	Time to progress	The period from enrollment to disease progression	From enrollment to disease progression, up to 6 months
Secondary	Adverse effect	Any adverse effects occur during the project	1 year