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Advanced Primary Liver CancerPhase 2NCT03092895

A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC

A Phase 2 study testing SHR-1210, Apatinib and FOLFOX4 in people with Advanced Primary Liver Cancer and Advanced Biliary Tract Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SHR-1210, Apatinib and FOLFOX4
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
7 sitesChina
Study dates
24 Apr 2017to 31 Mar 2021
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
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  • 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.
  • Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
  • Proteinuria≥ 2+ or 24 hours total urine protein > 1.0 g.
  • Active known, or suspected autoimmune disease.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily. prednisone equivalent, are permitted in the absence of active autoimmune disease
  • Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
  • Prior therapy with anti-PD-1 or other anti-PD-1/anti-PD-L1 immunotherapy.
  • Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
  • Treatment with anti-coagulation therapy(Warfarin or heparin) or anti-platelet therapy(aspirin at dose≥300mg/day, clopidogrel at dose≥75mg/day).
  • Pregnant or breast-feeding women.
  • According to the investigator, other conditions that may lead to stop the research.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230000

  • Hunan Cancer Hospital

    Hunan, Changsha, 410000

  • The First Affiliated Hospital of Nanchang University

    Jiangxi, Nanchang, 330006

  • 81 Hospital Nanjing

    Nanjing, Jiangsu, 210002

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200003

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Cancer Hospital of Henan province

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: 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)

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.

Being tested
SHR-1210, Apatinib, FOLFOX4, GEMOX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Biological

    Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks

  • ApatinibDrug

    Subjects receive Apatinib orally every day with a dose escalation

  • FOLFOX4Drug

    Subjects receive FOLFOX4 treatment every 2 weeks

  • GEMOXDrug

    Subjects receive GEMOX treatment every 2 weeks

Study groups in NCT03092895
Study groupRoleWhat they receive
SHR-1210+Apatinib(Arm A）ExperimentalNot described
Receives: Biological: SHR-1210; Drug: Apatinib
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）ExperimentalNot described
Receives: Biological: SHR-1210; Drug: FOLFOX4; Drug: GEMOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Safety and Tolerability

    The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03

    Measured: Up to approximately 4 years

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by investigator: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to approximately 4 years

  2. Duration of Response (DoR)

    The time from the date of the first recorded objective tumor response (assessed as per RECIST V1.1) to the date of the first recorded objective tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first, in subjects with a BOR of CR or PR.

    Measured: Up to approximately 4 years

  3. Disease Control Rate (DCR)

    The percentage of subjects with a BOR of CR, PR, and SD as per RECIST V1.1. BOR of CR or PR must be confirmed at least 4 weeks (28 days) after the initial assessment.

    Measured: Up to approximately 4 years

  4. Time to Progression (TTP)

    The time from the date of the first dose to the date of radiographic PD (assessed by the investigator as per RECIST V1.1).PD is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or significant progression of non-target lesions leading to discontinuation of therapy, or the appearance of new lesions.

    Measured: Up to approximately 4 years

  5. Overall Survival

    The time from the date of the first dose to death due to any cause. Overal Survial will be calculated based on Kaplan-Meier estimates

    Measured: Up to approximately 4 years

  6. Time to Response (TTR)

    The time from the date of the first dose to the date of the first recorded tumor response (assessed as per RECIST V1.1) in subjects with a BOR of CR or PR.

    Measured: Up to approximately 4 years

  7. Progression-free Survival (PFS)

    The time from the date of the first dose to the date of the first recorded tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first.

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start24 Apr 2017
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092895
Sponsor's protocol ID
SHR-1210-APTN-II-203-PLC
Status last verified
Apr 2022
First submitted
15 Mar 2017
Last updated
29 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34309846

  • Mei 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.

    PubMed 33741732

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