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

Phase 1

• Conditions: Hepatocellular Carcinoma; Liver Transplant
• Interventions: Drug: Camrelizumab plus apatinib

• Registration Number: NCT04035876
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-16
• Study First Submitted: 2019-07-20
• Study First Submitted QC: 2019-07-26
• Last Update Submitted: 2019-07-26
• Study First Posted: 2019-07-29
• Last Update Posted: 2019-07-29
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab plus apatinib	Camrelizumab plus apatinib	-

Primary Outcome Measures

Name	Time	Method
Objective remission rate	From enrollment to disease progression, up to 6 months	The proportion of patients with CR, PR, and SD in the group
Recurrence-free survival	1 year	The period from enrollment surgery to recurrence of HCC

Secondary Outcome Measures

Name	Time	Method
Adverse effect	1 year	Any adverse effects occur during the project
Time to progress	From enrollment to disease progression, up to 6 months	The period from enrollment to disease progression
Overall survival	1 year	The survival rate in a year

Trial Locations

Locations (1)

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China