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

January 12, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The Second Affiliated Hospital of Anhui Medical University
    • Changsha
      • Hunan, Changsha, China, 410000
        • Hunan Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Cancer Hospital of Henan province
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • 81 Hospital Nanjing
    • Nanchang
      • Jiangxi, Nanchang, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200003
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  1. Histologically confirmed advanced PLC or advanced BTC (including bile duct carcinoma and gallbladder carcinoma) ; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1.
  2. Arm A:Failed or intolerable to at least one prior systemic treatment for advanced PLC. Arm B:No previous systemic treatment for advanced PLC or BTC
  3. ECOG Performance Status of 0 or1.
  4. Child-Pugh Class A or B with 7 points .
  5. Life Expectancy of at least 12 weeks.
  6. Has controlled infection by Hepatitis B Virus (HBV DNA<500 IU/ml) or Hepatitis C Virus.
  7. Adequate organ function.
  8. Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug.
  9. Patient has given written informed consent.

Exclusion Criteria:

  1. Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
  2. Known or occurrence of central nervous system (CNS) metastases.
  3. Ascites with clinical symptoms.
  4. Known or evidence of GI hemorrhage within the past 6 months.
  5. Known or occurrence of hemorrhage/ thrombus.
  6. Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months.
  7. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
  8. Grade III~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
  9. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg).
  10. 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).
  11. History of hepatic encephalopathy.
  12. Known history of human immunodeficiency virus (HIV) infection.
  13. Active infection or an unexplained fever > 38.5°C during screening visits.
  14. Has received a live vaccine within 30 days.
  15. Prior or planning to organ transplantation including liver transplantation.
  16. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
  17. Proteinuria≥ 2+ or 24 hours total urine protein > 1.0 g.
  18. Active known, or suspected autoimmune disease.
  19. 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
  20. Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
  21. Prior therapy with anti-PD-1 or other anti-PD-1/anti-PD-L1 immunotherapy.
  22. Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
  23. Treatment with anti-coagulation therapy(Warfarin or heparin) or anti-platelet therapy(aspirin at dose≥300mg/day, clopidogrel at dose≥75mg/day).
  24. Pregnant or breast-feeding women.
  25. According to the investigator, other conditions that may lead to stop the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SHR-1210+Apatinib(Arm A）
Biological: SHR-1210
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
Drug: Apatinib
Subjects receive Apatinib orally every day with a dose escalation
Experimental: SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）
Biological: SHR-1210
Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
Drug: FOLFOX4
Subjects receive FOLFOX4 treatment every 2 weeks
Drug: GEMOX
Subjects receive GEMOX treatment every 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Safety and Tolerability
Time Frame: Up to approximately 4 years
The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Up to approximately 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
Duration of Response (DoR)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
Disease Control Rate (DCR)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
Time to Progression (TTP)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
Overall Survival
Time Frame: Up to approximately 4 years
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
Up to approximately 4 years
Time to Response (TTR)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
Progression-free Survival (PFS)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-1210-APTN-II-203-PLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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