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Nasopharyngeal CarcinomaPhase 2NCT04586088

Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure

A Phase 2 study testing Apatinib plus Camrelizumab in people with Nasopharyngeal Carcinoma and Recurrent 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the first-line treatment. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Apatinib plus Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
5 May 2020to 5 Sep 2023
Phase
Phase 2
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 metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment
  • Underwent at least first-line treatment failure
  • 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.
  • 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 Camrelizumab formulation or other monoclonal antibodies ;
  • 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 4 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
  • Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs.
  • Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN) with bleeding tendency.
  • The laboratory test values within 7 days before enrollment do not meet the relevant standards.
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  • Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
  • Diagnosed with other malignant tumors.
  • Uncontrolled clinically significant medical condition, including but not limited to the following:
  • Hypertension that cannot be reduced to the normal range after antihypertensive drug
  • congestive heart failure (New York Health Authority Class \> 2),
  • unstable angina,
  • myocardial infarction within the past 12 months,
  • clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
  • Active bleeding, ulcer, intestinal perforation, major surgery in the previous month; Patients with tumors close to the internal carotid artery or other large vessels, thus at risk of massive bleeding
  • Active infection or an unexplained fever; 38.5°C 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; active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening; 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.
  • Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
  • 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;

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: Apatinib Combined With Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Failed at Least the First-line Treatment

This is a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the first-line treatment.

Being tested
Apatinib plus Camrelizumab
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Apatinib plus CamrelizumabDrug

    Subjects receive Apatinib, 250mg, QD and Camrelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.

Study groups in NCT04586088
Study groupRoleWhat they receive
Apatinib plus Camrelizumab armExperimentalSubjects receive apatinib plus camrelizumab
Receives: Drug: Apatinib plus Camrelizumab

What is being measured

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

  1. Objective response rate

    Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1

    Measured: 1 year

Secondary outcomes (5)

  1. The proportion of patients who achieved disease control

    Defined as the proportion of subjects who achieve CR+PR+stable disease (SD) for at least 4 weeks according to RECIST 1.1.

    Measured: 1 year

  2. The proportion of patients who achieved clinical benefit

    Defined as maintaining the efficacy of CR+PR+SD for at least 6 months according to RECIST 1.1.

    Measured: 1 year

  3. median progression-free survival

    Defined as the period from the start of enrollment until disease progression or death from any cause.

    Measured: 1 year

  4. Duration of response

    Defined as the time from the first assessment of CR and PR to the first assessment of PD or death caused by any cause according to RECIST 1.1.

    Measured: 1 year

  5. Adverse events

    NCI-CTC5.0 standard was adopted, and the safety was assessed mainly by clinical laboratory tests, ECOG-PS score, physical examination, electrocardiogram, and adverse event results.

    Measured: 1 year

Timeline

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

  1. First posted14 Oct 2020
  2. Study start5 May 2020
  3. Primary completion2 Jun 2022
  4. Study completion5 Sep 2023 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586088
Sponsor's protocol ID
SYSUCC-CMY-2020-2103
Status last verified
May 2023
First submitted
7 Oct 2020
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ding X, Zhang WJ, You R, Zou X, Wang ZQ, Ouyang YF, Peng L, Liu YP, Duan CY, Yang Q, Lin C, Xie YL, Chen SY, Liu YL, Gu CM, Xie RQ, Huang PY, Hong MH, Hua YJ, Chen MY. Camrelizumab Plus Apatinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: An Open-Label, Single-Arm, Phase II Study. J Clin Oncol. 2023 May 10;41(14):2571-2582. doi: 10.1200/JCO.22.01450. Epub 2023 Feb 3.

    PubMed 36735896

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib plus Camrelizumab in people with Nasopharyngeal Carcinoma and Recurrent 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 19 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 6 May 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective response rate (time frame: 1 year). 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 NCT04586088, 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 6 May 2023.

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