A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)
1 other identifier
interventional
157
1 country
7
Brief Summary
This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2017
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
March 28, 2017
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
January 29, 2026
CompletedJanuary 29, 2026
April 1, 2022
3.9 years
March 15, 2017
July 4, 2023
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The Safety and Tolerability
The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Up to approximately 4 years
Secondary Outcomes (7)
Objective Response Rate (ORR)
Up to approximately 4 years
Duration of Response (DoR)
Up to approximately 4 years
Disease Control Rate (DCR)
Up to approximately 4 years
Time to Progression (TTP)
Up to approximately 4 years
Overall Survival
Up to approximately 4 years
- +2 more secondary outcomes
Study Arms (2)
SHR-1210+Apatinib(Arm A）
EXPERIMENTALSHR-1210+FOLFOX4 or GEMOX regimen(Arm B）
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
- Known or occurrence of central nervous system (CNS) metastases.
- Ascites with clinical symptoms.
- Known or evidence of GI hemorrhage within the past 6 months.
- Known or occurrence of hemorrhage/ thrombus.
- Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months.
- Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
- Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90 mmHg).
- Factors to affect oral administration (such as patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption).
- History of hepatic encephalopathy.
- Known history of human immunodeficiency virus (HIV) infection.
- Active infection or an unexplained fever \> 38.5°C during screening visits.
- Has received a live vaccine within 30 days.
- Prior or planning to organ transplantation including liver transplantation.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, 230000, China
Hunan Cancer Hospital
Hunan, Changsha, 410000, China
Cancer Hospital of Henan province
Zhengzhou, Henan, 450008, China
81 Hospital Nanjing
Nanjing, Jiangsu, 210002, China
The First Affiliated Hospital of Nanchang University
Jiangxi, Nanchang, 330006, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200003, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (2)
Chen X, Qin S, Gu S, Ren Z, Chen Z, Xiong J, Liu Y, Meng Z, Zhang X, Wang L, Zhang X, Zou J. Camrelizumab plus oxaliplatin-based chemotherapy as first-line therapy for advanced biliary tract cancer: A multicenter, phase 2 trial. Int J Cancer. 2021 Dec 1;149(11):1944-1954. doi: 10.1002/ijc.33751. Epub 2021 Sep 8.
PMID: 34309846DERIVEDMei K, Qin S, Chen Z, Liu Y, Wang L, Zou J. Camrelizumab in combination with apatinib in second-line or above therapy for advanced primary liver cancer: cohort A report in a multicenter phase Ib/II trial. J Immunother Cancer. 2021 Mar;9(3):e002191. doi: 10.1136/jitc-2020-002191.
PMID: 33741732DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Wei Shi
- Organization
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2017
First Posted
March 28, 2017
Study Start
April 24, 2017
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
January 29, 2026
Results First Posted
January 29, 2026
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share