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

Last updated: July 26, 2019
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Hepatic Fibrosis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT04035876
KY2019-SHR-APA-ZJU
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-75 years

  • Pathology: hepatocellular carcinoma

  • Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor andAFP ≤ 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 ≤ 1.5ULN

  • ECOG: 0-2

  • Patients participate in the study voluntarily and sign informed consent

Exclusion

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 orintravenous steroid therapy

  • Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form ofimmunosuppressive therapy

  • Myocardial ischemia or myocardial infarction above grade II, hypertension andinability 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 ofgastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoingthrombolytic 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

Total Participants: 120
Study Start date:
July 16, 2019
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Medical School of Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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