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Nasopharyngeal CarcinomaPhase 1NCT04073784

Gemcitabine Combined With Apatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.

A Phase 1 study testing Gemcitabine combined with Aptinib and Toripalimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma. 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?
Gemcitabine combined with Aptinib and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
8 Jun 2019to 1 Apr 2024
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 organ function assessed by laboratory parameters during the screening period
  • 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 Toripalimab 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,
  • 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.
  • Subjects with hypertension (even with antihypertensive treatment) unable to reduce to the normal range. (Systolic blood pressure >140 mmHg/diastolic blood pressure > 90 mmHg ). Coronary heart disease, arrhythmia ≥II (including QTc lengthened, men > 450 ms, women > 470 ms) and cardiac failure.
  • Coagulation abnormalities (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
  • Patients with or previous with serious hemorrhage (bleeding > 30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Gemcitabine Combined With Apatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma

This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma.

Read the detailed description

This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma.

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
Gemcitabine combined with Aptinib and Toripalimab
Keywords
Toripalimab, Gemcitabine, Apatinib, recurrent NPC, metastatic NPC
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Gemcitabine combined with Aptinib and ToripalimabDrug

    Gemcitabine injection, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles.

    Apatinib for oral administration, 250mg, once a day. Apatinib maintenance.

    Toripalimab injection, 240mg, Day 1 each 21day. Toripalimab maintenance.

Study groups in NCT04073784
Study groupRoleWhat they receive
Gemcitabine combined with Apatinib and ToripalimabExperimentalSubjects receive Apatinib for oral administration, 250mg, once a day, gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) and Apatinib 250mg once a day maintenance for the remainder of the study or until documented PD.
Receives: Drug: Gemcitabine combined with Aptinib and Toripalimab

What is being measured

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

  1. Adverse events

    The safety 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.

    Measured: 12months

Secondary outcomes (5)

  1. The proportion of patients who achieved an objective response

    Defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;

    Measured: 12 months

  2. The proportion of patients who achieved disease control,

    Defined as those with RECIST-defined objective response or stable disease;

    Measured: 12months

  3. The proportion of patients who achieved clinical benefit

    Defined as those with confirmed objective response or stable disease that lasted for at least 6 months;

    Measured: 12 months

  4. Progression-free survival (median and at 6 and 12 months)

    Defined from the enrolment to RECISTdefined progression or death from any causes;

    Measured: 12 months

  5. Duration of response

    Defined as the time from first documentation of objective response to radiological disease progression.

    Measured: 12 months

Timeline

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

  1. First posted29 Aug 2019
  2. Study start8 Jun 2019
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2024 (estimated)

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
Model description
Subjects receive Apatinib for oral administration, 250mg, once a day, gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) and Apatinib 250mg once a day maintenance for the remainder of the study or until documented PD.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04073784
Sponsor's protocol ID
SYSUCC-BYK-GAT2019
Status last verified
Apr 2022
First submitted
25 Aug 2019
Last updated
26 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • You R, Zou X, Ding X, Zhang WJ, Zhang MX, Wang X, Xu HS, Liu YL, Ouyang YF, Duan CY, Gu CM, Wang ZQ, Liu YP, Hua YJ, Huang PY, Chen MY. Gemcitabine combined with apatinib and toripalimab in recurrent or metastatic nasopharyngeal carcinoma. Med. 2022 Oct 14;3(10):664-681.e6. doi: 10.1016/j.medj.2022.07.009. Epub 2022 Aug 29.

    PubMed 36041429

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine combined with Aptinib and Toripalimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 26 Apr 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?

Results are not available in the source record.

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?

Adverse events (time frame: 12months). 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 NCT04073784, 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 26 Apr 2022.

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