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

NCT04035876 | Unknown Phase 1

• 1 other identifier: KY2019-SHR-APA-ZJU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma; Liver Transplant

Keywords

Camrelizumab; Apatinib; HCC; Liver transplantation

Outcome Measures

Primary Outcomes (2)

• Objective remission rate

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

  From enrollment to disease progression, up to 6 months

• Recurrence-free survival

  The period from enrollment surgery to recurrence of HCC

  1 year

Secondary Outcomes (3)

• Overall survival

  1 year

• Time to progress

  From enrollment to disease progression, up to 6 months

• Adverse effect

  1 year

Study Arms (1)

Camrelizumab plus apatinib

EXPERIMENTAL

Drug: Camrelizumab plus apatinib

Interventions

Camrelizumab plus apatinib DRUG

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

Camrelizumab plus apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jianguo Wang, PhD

CONTACT

(+86)15967123327; 21118059@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 29, 2019
• Study Start: July 16, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)