Nasopharyngeal CarcinomaPhase 2NCT05981157
Anrotinib and Tirelizumab in First-line Treatment of RM-NPC
A Phase 2 study testing Anrotinib plus Tirelizumab in people with Nasopharyngeal Carcinoma, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial summary
This is a prospective phase II clinical trial to evaluate the efficacy and safety of Anrotinib and Tirelizumab as a first-line treatment in patients with advanced recurrent or metastatic nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Anrotinib plus Tirelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary; locoregional recurrent lesion unfit for local treatment).
- Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
- ECOG performance status of 0～2
- Life expectancy more than 12 weeks.
- unable or unwilling to undergo chemothraphy
- Able to understand and sign an informed consent form (ICF).
Who cannot join
- 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;
- Known history of hypersensitivity to any components of the Tirelizumab formulation or other monoclonal antibodies ;
- Diagnosed with other malignant tumors.
- 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;
- Subjects with medical condition affecting oral drug absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
- 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.
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- The laboratory test values within 7 days before enrollment do not meet the relevant standards.
- 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;
- 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.
- Subjects with comorbidities with long-term immunosuppressive drug therapy, or with systemic or local use of immunosuppressive doses of corticosteroids.
- 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.
- 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, 1 recruiting
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403
Guiqiong Xu, +8613528109888, donna_shee@163.com
About this study
Official title: Anrotinib Combined With Tirelizumab in First-line Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
This is a prospective phase II clinical trial to evaluate the efficacy and safety of Anrotinib and Tirelizumab as a first-line treatment in patients with advanced recurrent or metastatic nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Anrotinib plus Tirelizumab
- Keywords
- nasopharyngeal carcinoma, Immunotherapy, Molecular Targeted Therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anrotinib plus TirelizumabDrug
Subjects receive Anrotinib, 10mg, QD and Tirelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.
| Study group | Role | What they receive |
|---|---|---|
| Anrotinib plus Tirelizumab arm | Experimental | Subjects receive anrotinib plus tirelizumab Receives: Drug: Anrotinib plus Tirelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
progression-free survival
Defined as the period from the start of enrollment until disease progression or death from any cause.
Measured: 1 year
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.
- First posted8 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gui-Qiong Xu, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981157
- Sponsor's protocol ID
- ZSCPH-001
- Status last verified
- Jul 2023
- First submitted
- 16 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anrotinib Combined With Tirelizumab in First-line Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05981157
- Acronym / sponsor ID
- ZSCPH-001
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, Immunotherapy, Molecular Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective phase II clinical trial to evaluate the efficacy and safety of Anrotinib and Tirelizumab as a first-line treatment in patients with advanced recurrent or metastatic nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anrotinib plus Tirelizumab arm | Experimental | Drug: Anrotinib plus TirelizumabSubjects receive anrotinib plus tirelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary; locoregional recurrent lesion unfit for local treatment).
- Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
- ECOG performance status of 0～2
- Life expectancy more than 12 weeks.
- unable or unwilling to undergo chemothraphy
Key exclusion criteria (13 listed)
- 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;
- Known history of hypersensitivity to any components of the Tirelizumab formulation or other monoclonal antibodies ;
- Diagnosed with other malignant tumors.
- 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;
- Subjects with medical condition affecting oral drug absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anrotinib plus TirelizumabSubjects receive Anrotinib, 10mg, QD and Tirelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision. | Drug | Anrotinib plus Tirelizumab arm |
Primary outcome
Objective response rate
Time frame: 1 year
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
5 secondary outcomes
The proportion of patients who achieved disease control
Time frame: 1 year
The proportion of patients who achieved clinical benefit
Time frame: 1 year
Duration of response
Time frame: 1 year
progression-free survival
Time frame: 1 year
Adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anrotinib plus Tirelizumab in people with Nasopharyngeal Carcinoma, run by Zhongshan People's Hospital, Guangdong, China 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 6 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: status not confirmed, as of the sponsor's last update on 8 Aug 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?
Contact Guiqiong Xu, MD (+8613528109888, donna_shee@163.com), or a site near the patient. 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?
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 8 Aug 2023.