A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC

NCT03793725 | Unknown Phase 2

• 1 other identifier: HZ-T-PD1-APA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma. This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• R0 (resection rate)

  R0 resection rate

  1 week after surgery

Secondary Outcomes (2)

• ORR

  from the first drug administration up to one year

• RFS

  from the first drug administration up to one year

Study Arms (1)

SHR-1210 + Apatinib

EXPERIMENTAL

Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd

Drug: SHR1210; Drug: Apatinib

Interventions

SHR1210 DRUG

Anti-PD-1 Antibody

SHR-1210 + Apatinib

Apatinib DRUG

Anti-angiogenic drugs

SHR-1210 + 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:

• Subjects voluntarily participate in this study and sign informed consent .
• Men or women aged 18-75 years
• patients with Unresectable HCC confirmed histologically or cytologically or clinically，At least one measurable lesion that meets the RECIST v1.1 criteria without local treatment.
• The patients can swallow pills normally.
• ECOG score was 0 or 1.
• Have a life expectancy of at least 12 weeks.
• The functions of vital organs meet the following requirements (excluding the use of any blood components and cytokines during screening) : Neutrophils≥1.5 x 109/L, Hb≥9g/dL; Plt≥90 x 109/L, ALB≥3g/dL, TSH≤ULN(Upper Limit Of Norma), TBIL ≤ 1.25 x ULN, ALT and AST ≤ 1.5 x ULN, AKP≤ 2.5 x ULN, CR≤ 1.5 x ULN
• Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.

You may not qualify if:

• Subjects had any active autoimmune disease or history of autoimmune disease.
• Subjects are using immunosuppressive agents, or systemic, or absorptive,local hormone therapy to achieve immunosuppression. It is still in use within 2 weeks before enrollment.
• Subjects with severe allergic reactions to other monoclonal antibodies.
• The subjects had a central nervous system metastases of clinical symptoms.
• A heart condition or disease that is not well controlled.
• Subjects had active infections.
• Other clinical trials of drugs were used within 4 weeks prior to the first administration.
• The subjects have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 or CDK4/6 inhibitor treatment in the past.
• There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.

Sponsors & Collaborators

• Yanqiao Zhang: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

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

Study Officials

• Zhang Yanqiao, PHD

  Study Principal Investigator Harbin Medical University Cancer Hosptital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Yanqiao, PHD

CONTACT

138 4512 0210; yanqiaozhang@126.com

Wang Guangyu, PHD

CONTACT

18249038966; 18249038966@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the hospital

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: January 30, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2021
• Last Updated: January 4, 2019

Record last verified: 2019-01