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Nasopharyngeal CarcinomaPhase 1NCT03121716

A Study to Evaluate the Safety and Efficacy of SHR-1210, Gemcitabine and Cis-platinum by R/M NPC Subjects

A Phase 1 study testing SHR-1210, Gemcitabine and cis-platinum in people with Nasopharyngeal Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by recurrent and metastatic NPC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
SHR-1210, Gemcitabine and cis-platinum
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
26 Apr 2017to 31 Jul 2020
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Male or female 18-70 years of age.
  • Subjects diagnosed with pathological confirmed Primary metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment.
  • Subjects with recurrent and metastatic NPC who did't receive any Systemic chemotherapy, neoadjuvant chemotherapy, concurrent radiochemotherapy and adjuvant chemotherapy 6 month before first dose are excepted.
  • ECOG performance status of 0 or 1.
  • Life expectancy more than 12 weeks.
  • Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
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  • Adequate laboratory parameters during the screening period as evidenced by the following:
  • Absolute neutrophil count ≥1.5*10E9/L;
  • Platelets ≥100*10E9/L;
  • Hemoglobin ≥9.0 g/dL;
  • Albumin (ALB) levels ≥2.8 g/dL;
  • Total bilirubin (TBIL)≥1.5 upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 upper limit of normal(ULN); for subjects with liver metastases, ALT and AST ≥5 ULN;
  • creatinine clearance rate ≥50mL/min;
  • Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy. A highly effective method of contraception is defined as one that results in a low failure rate, that is, less than 1% per year when used consistently and correctly
  • Able to understand and sign an informed consent form (ICF).

Who cannot join

  • Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
  • Known history of hypersensitivity to any components of the SHR-1210 formulation;
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
  • Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
  • Uncontrolled clinically significant medical condition, including but not limited to the following:
  • congestive heart failure (New York Health Authority Class \> 2),
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  • unstable angina,
  • myocardial infarction within the past 12 months, or
  • clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
  • Active infection or an unexplained fever; 38.5℃ during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
  • History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease;
  • Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Hengrui

    Shanghai

Other trials in China

About this study

Official title: An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by recurrent and metastatic NPC.

Read the detailed description

This is an open-label, single center, nonrandomized, Phase 1 study to evaluate safety and efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by recurrent and metastatic NPC.

The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.

Being tested
SHR-1210, Gemcitabine, cis-platinum
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • SHR-1210Biological

    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

  • GemcitabineDrug

    Also called Gemcitabine Hydrochloride for Injection

    gemcitabine

  • cis-platinumDrug

    Also called Cisplantin Injection

    cis-platinum

Study groups in NCT03121716
Study groupRoleWhat they receive
SHR-1210, gemcitabine and cis-platinumExperimentalSubjects receive SHR-1210 200mg (Day 1) and gemcitabine 1000mg/m2 (Day 1 and Day 8)and cis-platinum 80mg/m2 (Day 1) of each 21-day cycle for at most 6 cycles, followed by SHR-1210 200mg every three weeks (Q3W) maintenance for the remainder of the study or until documented PD.
Receives: Biological: SHR-1210; Drug: Gemcitabine; Drug: cis-platinum

What is being measured

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

  1. progression of disease

    progression of disease by radiographic examination

    Measured: 28 days

Timeline

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

  1. First posted20 Apr 2017
  2. Study start26 Apr 2017
  3. Primary completion28 Jul 2020
  4. Study completion31 Jul 2020

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121716
Sponsor's protocol ID
SHR-1210-104
Status last verified
Dec 2018
First submitted
13 Apr 2017
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10.

    PubMed 30213452

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1210, Gemcitabine and cis-platinum in people with Nasopharyngeal Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression of disease (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03121716, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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