Nasopharyngeal CarcinomaPhase 3NCT05342792
Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma
A Phase 3 study testing PD-1 antibody and Capecitabine in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- PD-1 antibody and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2022to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at diagnosis: 18 ~ 65 years old;
- Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
- Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 8th edition clinical staging system.
- Induction and concurrent chemoradiotherapy with the recommended regimen have been completed;
- ECOG score: 0 ~ 1 points (Appendix II);
- It is recommended to initiate adjuvant therapy within 1 month after the completion of the last radiotherapy treatment, no later than 6 weeks;
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- Normal bone marrow function: white blood cell count > 4 × 109/L, hemoglobin concentration > 90 g/L, platelet count > 100 × 109/L;
- Normal liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of normal; aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 times the upper limit of normal; alkaline phosphatase ≤ 2.5 times the upper limit of normal; creatinine clearance ≥ 60 mL/min;
- Subjects must sign the informed consent form, and must be willing and able to comply with the visits, treatment regimen, laboratory tests and other requirements specified in the study protocol;
- Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use reliable contraception (e.g., condoms, regular contraceptives as directed) from screening through 1 year after treatment.
Who cannot join
- Positive hepatitis B surface antigen and hepatitis B virus quantification > 1 × 1000 copies/ml, or positive anti-hepatitis C virus antibody;
- Positive anti-HIV antibody or diagnosis of acquired immunodeficiency syndrome (i.e., AIDS);
- Conditions such as dysphagia, chronic diarrhea, or bowel obstruction that would interfere with oral medication.
- Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal or antiviral therapy before randomization, including but not limited to tuberculosis infection
- Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchiectasis). Except for type I diabetes, hypothyroidism requiring hormone replacement therapy and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia); clinicians should perform necessary history, examination and examination before enrollment for the above diseases and then exclude them;
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year;
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- Definite clinical evidence of persistent local disease or distant metastasis after chemoradiotherapy;
- Systemic hormonal or other immunosuppressive therapy with an equivalent dose of > 10 mg prednisone/day within 28 days prior to informed consent. Subjects with systemic sex hormone doses ≤ 10 mg prednisone/day or inhaled/topical corticosteroids may be included.
- Uncontrolled heart disease, such as: 1) heart failure, NYHA level ≥ 2; 2) unstable angina; 3) history of myocardial infarction in the past year; 4) supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
- Pregnant or lactating women (pregnancy test should be considered for sexually active women of childbearing age);
- Previous or current other malignancy other than adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma;
- Receipt of live vaccines within 30 days prior to the first course of tislelizumab;
- History of organ transplantation;
- Other conditions that may jeopardize patient safety or compliance as assessed by the investigator, such as serious illness (including psychiatric disorders) requiring prompt treatment, severely abnormal test results, and other family or social risk factors.
- Patients who received surgical treatment, biological therapy, or immunotherapy during or before radiotherapy;
- Patients who are receiving or are likely to receive other chemotherapy, biological therapy, or immunotherapy History of severe hypersensitivity to other monoclonal antibodies;
- Chemotherapy or surgery (except diagnostic) of the primary tumor or lymph nodes before standard treatment.
- History of radiation therapy prior to standard therapy (except for non-melanoma skin cancer).
- Patients who are known to be intolerable or sensitive to any therapeutic agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jun Ma, M.D., +86-20-87343469, majun2@mail.sysu.edu.cn
Jun Ma, M.D.
About this study
Official title: Metronomic Capecitabine With or Without Tislelizuamb (PD-1 Antibody) as Adjuvant Therapy in High-risk Non-metastatic Nasopharyngeal Carcinoma: a Multicentre, Open-label, Randomised Phase 3 Trial
This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.
Read the detailed description
In this multicenter, randomised controlled, phase 3 trial, patients with T4N+/TanyN2-3 (AJCC/UICC 8th system), or non-metastatic nasopharyngeal carcinoma with pretreatment EBV DNA > 4000 copies/ml, will be randomized in a 1:1 ratio to receive metronomic capecitabine with or without PD-1 antibody every 3 weeks for 1 year after curative chemoradiation.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- PD-1 antibody, Capecitabine
- Keywords
- PD-1 antibody, Metronomic capecitabine, Adjuvant 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.
PD-1 antibodyDrug
Also called Tislelizumab
Tislelizumab：200 mg per dose, intravenous infusion over 30 minutes, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy
CapecitabineDrug
Capecitabine : 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Metronomic Capecitabine with PD-1 antibody arm | Experimental | Patients randomised to this arm will receive metronomic capecitabine (650mg/m2, BID, PO) and Tislelizuamb (200mg, iv drip, Q3W) for 1 year as adjuvant therapy, beginning 4-6 weeks after chemoradiation. Receives: Drug: PD-1 antibody; Drug: Capecitabine |
| Metronomic Capecitabine alone arm | Active comparator | Patients randomised to this arm will receive metronomic capecitabine (650mg/m2, BID, PO) alone for 1 year as adjuvant therapy, beginning 4-6 weeks after chemoradiation. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure-free survival
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
Measured: 3 years
Secondary outcomes (5)
overall survival
calculated from date of randomisation to death
Measured: 5 years
distant metastasis-free survival
calculated from date of randomisation to the first distant failure
Measured: 3 years
locoregional recurrence-free survival
locoregional recurrence-free survival
Measured: 3 years
adverse events (AEs) and severe adverse events (SAE)
graded according to NCI CTCAE v5.0
Measured: 5 years
quality of life (QoL)
the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start17 Apr 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xiangya Hospital of Central South University, Affiliated Cancer Hospital of Guizhou Medical University, Cancer Hospital of Guangxi Medical University, First People's Hospital of Foshan, Chongqing University Cancer Hospital, Hubei Cancer Hospital, Hunan Cancer Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Fifth Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital
- Responsible party
- Principal investigator, Jun Ma, MD, Sun Yat-sen University
- Investigators
- Jun Ma, MD, Principal investigator, Sun Yet-senU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342792
- Sponsor's protocol ID
- SL-B2022-202-02
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete de-identified patient data set
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronomic Capecitabine With or Without Tislelizuamb (PD-1 Antibody) as Adjuvant Therapy in High-risk Non-metastatic Nasopharyngeal Carcinoma: a Multicentre, Open-label, Randomised Phase 3 Trial
- ClinicalTrials.gov ID
- NCT05342792
- Acronym / sponsor ID
- SL-B2022-202-02
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- PD-1 antibody, Metronomic capecitabine, Adjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xiangya Hospital of Central South University, Affiliated Cancer Hospital of Guizhou Medical University, Cancer Hospital of Guangxi Medical University, First People's Hospital of Foshan, Chongqing University Cancer Hospital, Hubei Cancer Hospital, Hunan Cancer Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Fifth Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 25 Apr 2022 (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 trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.
Detailed description
In this multicenter, randomised controlled, phase 3 trial, patients with T4N+/TanyN2-3 (AJCC/UICC 8th system), or non-metastatic nasopharyngeal carcinoma with pretreatment EBV DNA > 4000 copies/ml, will be randomized in a 1:1 ratio to receive metronomic capecitabine with or without PD-1 antibody every 3 weeks for 1 year after curative chemoradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronomic Capecitabine with PD-1 antibody arm | Experimental | Drug: PD-1 antibody, Drug: CapecitabinePatients randomised to this arm will receive metronomic capecitabine (650mg/m2, BID, PO) and Tislelizuamb (200mg, iv drip, Q3W) for 1 year as adjuvant therapy, beginning 4-6 weeks after chemoradiation. |
| Metronomic Capecitabine alone arm | Active comparator | Drug: CapecitabinePatients randomised to this arm will receive metronomic capecitabine (650mg/m2, BID, PO) alone for 1 year as adjuvant therapy, beginning 4-6 weeks after chemoradiation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age at diagnosis: 18 ~ 65 years old;
- Pathologically confirmed primary nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
- Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 8th edition clinical staging system.
- Induction and concurrent chemoradiotherapy with the recommended regimen have been completed;
- ECOG score: 0 ~ 1 points (Appendix II);
Key exclusion criteria (19 listed)
- Positive hepatitis B surface antigen and hepatitis B virus quantification > 1 × 1000 copies/ml, or positive anti-hepatitis C virus antibody;
- Positive anti-HIV antibody or diagnosis of acquired immunodeficiency syndrome (i.e., AIDS);
- Conditions such as dysphagia, chronic diarrhea, or bowel obstruction that would interfere with oral medication.
- Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal or antiviral therapy before randomization, including but not limited to tuberculosis infection
- Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchiectasis). Except for type I diabetes, hypothyroidism requiring hormone replacement therapy and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia); clinicians should perform necessary history, examination and examination before enrollment for the above diseases and then exclude them;
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 |
|---|---|---|
| PD-1 antibodyAlso: TislelizumabTislelizumab：200 mg per dose, intravenous infusion over 30 minutes, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy | Drug | Metronomic Capecitabine with PD-1 antibody arm |
| CapecitabineCapecitabine : 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy | Drug | Metronomic Capecitabine alone arm, Metronomic Capecitabine with PD-1 antibody arm |
Primary outcome
failure-free survival
Time frame: 3 years
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
5 secondary outcomes
overall survival
Time frame: 5 years
distant metastasis-free survival
Time frame: 3 years
locoregional recurrence-free survival
Time frame: 3 years
adverse events (AEs) and severe adverse events (SAE)
Time frame: 5 years
quality of life (QoL)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Complete de-identified patient data set
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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.
Jun Ma, MD principal investigator
Sun Yet-senU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD-1 antibody and Capecitabine 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 10 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: looking for participants now, as of the sponsor's last update on 25 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Ma, MD (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure-free survival (time frame: 3 years). 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 25 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.