Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal CarcinomaPhase 3NCT07925021
A Study of SYS6010 Combined With Enlonstobart in Patients With Previously Systemic Treatment-Naive R/M Nasopharyngeal Carcinoma
A Phase 3 study testing SYS6010 combined with Enlonstobart and Tislelizumab combined with chemotherapy in people with Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This is a randomized, open-label, multicenter phase Ⅲ trial to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-naive recurrent or metastatic nasopharyngeal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- SYS6010 combined with Enlonstobart and Tislelizumab combined with chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2026to 1 Dec 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged ≥ 18 years (as of the date of signed informed consent).
- Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma, with no prior systemic therapy for recurrent or metastatic nasopharyngeal carcinoma.
- For recurrent nasopharyngeal carcinoma: the disease is currently not eligible for local or curative-intent treatment, and the interval from completion of adjuvant/neoadjuvant therapy or concurrent chemoradiotherapy to disease recurrence must be more than 6 months. Metastatic nasopharyngeal carcinoma is defined as stage IV per AJCC 9.0 staging system.
- Willing to provide tumor tissue samples for testing of EGFR protein and PD-L1 expression. If sample collection is not feasible for certain reasons, eligibility will be determined by joint assessment of the investigator and sponsor
- At least one measurable lesion confirmed by CT or MRI per RECIST v1.1. The lesion has not received prior radiotherapy, or has demonstrated clear progression after prior radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Show all 13Show fewer
- Expected survival of the participant is ≥ 3 months.
- Major organ function must meet the following criteria within 7 days prior to enrollment:
- Complete blood count (no whole blood, red blood cell, or platelet transfusion, and no administration of hematopoietic growth factors [G-CSF or GM-CSF], erythropoietin [EPO], or thrombopoietin [TPO] to correct blood cell counts within 14 days before sampling):i. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;Platelet count (PLT) ≥ 100 × 10^9/L;Hemoglobin (HGB) ≥ 90 g/L.
- Blood biochemistry: Serum creatinine: Creatinine clearance ≥ 60 mL/min, calculated using the Cockcroft-Gault formula.; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (participants with Gilbert's syndrome may be allowed up to 3 × ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN for participants with liver metastasis).
- 3) Coagulation function: i. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy).
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the ICF until 7 months after the last study treatment dose (14 months after the last dose of cisplatin for female participants, and 11 months for male participants). Female participants shall not be breastfeeding during this period, and male participants must refrain from sperm donation
- Provides voluntary written informed consent after adequate understanding of the clinical trial.
Who cannot join
- Patients with leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastases (i.e., no midbrain, pons, or medulla oblongata involvement) may be enrolled if they have received local therapy, have achieved disease stability at least 2 weeks prior to the first dose of study intervention (no new brain metastases or enlargement of pre-existing brain metastatic lesions on imaging, all neurologic symptoms stabilized or returned to normal), and require no glucocorticoid treatment or receive prednisone at a daily dose ≤10 mg or equivalent doses of other glucocorticoids.
- History of other malignant neoplasms within 3 years prior to the first dose of study intervention, except for the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, etc.
- Known hypersensitivity to study drugs, any components of PD-1 inhibitors/gemcitabine/cisplatin, or humanized monoclonal antibody products.
- Prior treatment with antibody-drug conjugates (ADCs) carrying topoisomerase I inhibitor payloads.
- Adverse events from prior anti-tumor therapy that have not recovered to Grade ≤1 per NCI-CTCAE v6.0 (except for toxicities judged by the investigator to pose no safety risk such as alopecia); patients who experienced Grade ≥3 immune-related adverse events (irAEs) during prior therapy, or who permanently discontinued treatment due to irAEs
- Participants who fail to meet the required washout periods will be excluded.
Show all 20Show fewer
- History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose of study intervention, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as clinically significant ventricular arrhythmias requiring intervention, third-degree atrioventricular block, etc.; Fridericia-corrected QT interval >470 ms (Fridericia formula: QTcF=QT/RR⁰·³³, RR=60/heart rate);
- History of myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass graft surgery;
- New York Heart Association (NYHA) class Ⅱ or higher heart failure, or left ventricular ejection fraction <50% on screening assessment;
- Stroke or other grade ≥3 cardiovascular or cerebrovascular events;
- Pulmonary embolism; known deep vein thrombosis requiring intervention as judged by the investigator.
- Prior history of ILD / non-infectious pneumonitis requiring glucocorticoid treatment, current ILD / non-infectious pneumonitis, or ILD / non-infectious pneumonitis cannot be ruled out on screening imaging, or severe ventilatory dysfunction and/or impaired diffusion shown on pulmonary function test.
- Severe infection within 4 weeks prior to the first dose of study intervention, including but not limited to bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, etc.; active infection requiring systemic antibiotics within 2 weeks prior to the first dose of study intervention.
- Prior interruption of EGFR-targeted therapy for ≥1 month or permanent discontinuation due to skin toxicity, or current skin disease requiring oral or intravenous treatment.
- Participants with active autoimmune disease or history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.). Participants with the following conditions may proceed for screening: well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or participants whose disease is not expected to relapse in the absence of external triggers.
- Pleural, peritoneal or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose of study intervention.
- Active HBV or HCV infection (HBsAg positive with HBV-DNA ≥1×10⁴ copies/mL, or positive HCV antibody with HCV-RNA above the assay lower limit of detection), or HIV infection / diagnosed acquired immunodeficiency syndrome. Note: For HBsAg-positive subjects, antiviral therapy with nucleoside analogues such as entecavir or tenofovir disoproxil fumarate is recommended to be initiated before the first dose of study intervention.
- History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), or history of allogeneic stem cell or solid organ transplantation.
- Other conditions that, in the investigator's opinion, render the participant unsuitable for this clinical trial (e.g., psychiatric disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, etc.)
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, Guangzhou, 510060
Haiqiang Mai, Ph.D, 86-20-87343643, maihg@sysucc.org.cn
About this study
Official title: A Randomized, Open-label, Multicenter Phase Ⅲ Trial to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart Injection Versus Tislelizumab Combined With Chemotherapy (Gemcitabine Plus Cisplatin) in Patients With Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma
This is a randomized, open-label, multicenter phase Ⅲ trial to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-naive recurrent or metastatic nasopharyngeal carcinoma
Read the detailed description
This is a randomized, open-label, multicenter phase Ⅲ trial to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-naive recurrent or metastatic nasopharyngeal carcinoma. Approximately 424 eligible participants will be enrolled in the study.
Participants will continue to receive study treatments until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first).
All participants who discontinue study treatments will be followed for survival every 3 months (± 7 days) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (EOS) (whichever comes first). Additional survival follow-up calls may occur periodically, if needed.
- Being tested
- SYS6010 combined with Enlonstobart, Tislelizumab combined with chemotherapy
- Keywords
- Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010 combined with EnlonstobartDrug
Participants in the experimental group will receive SYS6010, administered on Day 1 of each cycle.
Participants in the experimental group will receive Enlonstobart, administered on Day 1 of each cycle.
Tislelizumab combined with chemotherapyDrug
Participants in the control group will receive:
Tislelizumab :200 mg, administered by intravenous infusion on D1 every 21-day treatment cycle; Gemcitabine: 1000 mg/m², administered by intravenous infusion on D1 and 8 of each 21-day cycle; Cisplatin: 80 mg/m², administered by intravenous infusion on D1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 combined with enlonstobart group | Experimental | Participants will receive SYS6010 combined with Enlonstobart Receives: Drug: SYS6010 combined with Enlonstobart |
| Tislelizumab+ chemotherapy | Active comparator | Participants will receive Tislelizumab combined with chemotherapy Receives: Drug: Tislelizumab combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Measured: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 37 months.
Secondary outcomes (15)
Overall Survival
Measured: From date of randomization to death due to any cause, up to approximately 60 months.
ORR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Objective Response Rate (ORR): Percentage of participants with confirmed complete response (CR) or partial response (PR) by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Measured: Up to approximately 24 months
DoR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Measured: Up to approximately 37 months.
DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Measured: Up to approximately 24 months.
PFS by the investigator based on RECIST v1.1.
Measured: Up to approximately 37 months.
ORR by the investigator based on RECIST v1.1.
Measured: Up to approximately 24 months.
DoR by the investigator based on RECIST v1.1.
Measured: Up to approximately 37 months.
DCR by the investigator based on RECIST v1.1.
Measured: Up to approximately 24 months.
Quality of life: participant head and neck cancer-specific quality of life after treatment assessed using the European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire Head and Neck Module (EORTC QLQ-H\&N35). Scores range from 0 to 100; higher scores mean worse quality of life / higher symptom burden.
Measured: Up to approximately 37 months.
Incidence of Adverse Events (AE) assessed by CTCAE 6.0.
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment assessed by CTCAE 6.0. The investigator assesses the relationship of each event to the use of study drug.
Measured: Up to approximately 37 months.
PK: Plasma concentration parameters (e.g., Cmax, AUC) for SYS6010 (toxin-conjugated antibody), total antibody, JS-1 and Enlonstobart.
Incidence, titer of anti-SYS6010 antibodies, and incidence of neutralizing antibodies (if applicable). PK assessments for SYS6010 (toxin-conjugated antibody, total antibody, JS-1) and Enlonstobart.
Measured: Up to approximately 37 months.
Serum concentrations of toxin-bound antibody of SYS6010.
Measured: Up to approximately 37 months.
Anti-Drug Antibodies (ADA): Incidence of anti-SYS6010 antibodies.
Measured: Up to approximately 37 months.
Anti-Drug Antibodies (ADA): Titer of anti-SYS6010 antibodies.
Measured: Up to approximately 37 months.
Anti-Drug Antibodies (ADA): Incidence of neutralizing antibodies (if applicable).
Measured: Up to approximately 37 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start6 Nov 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The 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
- Not applicable
- Intervention model
- Parallel groups
- Model description
- randomized, multicenter, open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925021
- Sponsor's protocol ID
- SYS6010-026
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase Ⅲ Trial to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart Injection Versus Tislelizumab Combined With Chemotherapy (Gemcitabine Plus Cisplatin) in Patients With Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07925021
- Acronym / sponsor ID
- SYS6010-026
- Keywords
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Nov 2026 (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 randomized, open-label, multicenter phase Ⅲ trial to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-naive recurrent or metastatic nasopharyngeal carcinoma
Detailed description
This is a randomized, open-label, multicenter phase Ⅲ trial to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-naive recurrent or metastatic nasopharyngeal carcinoma. Approximately 424 eligible participants will be enrolled in the study.
Participants will continue to receive study treatments until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first).
All participants who discontinue study treatments will be followed for survival every 3 months (± 7 days) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (EOS) (whichever comes first). Additional survival follow-up calls may occur periodically, if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, multicenter, open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| SYS6010 combined with enlonstobart group | Experimental | Drug: SYS6010 combined with EnlonstobartParticipants will receive SYS6010 combined with Enlonstobart |
| Tislelizumab+ chemotherapy | Active comparator | Drug: Tislelizumab combined with chemotherapyParticipants will receive Tislelizumab combined with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female participants aged ≥ 18 years (as of the date of signed informed consent).
- Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma, with no prior systemic therapy for recurrent or metastatic nasopharyngeal carcinoma.
- For recurrent nasopharyngeal carcinoma: the disease is currently not eligible for local or curative-intent treatment, and the interval from completion of adjuvant/neoadjuvant therapy or concurrent chemoradiotherapy to disease recurrence must be more than 6 months. Metastatic nasopharyngeal carcinoma is defined as stage IV per AJCC 9.0 staging system.
- Willing to provide tumor tissue samples for testing of EGFR protein and PD-L1 expression. If sample collection is not feasible for certain reasons, eligibility will be determined by joint assessment of the investigator and sponsor
- At least one measurable lesion confirmed by CT or MRI per RECIST v1.1. The lesion has not received prior radiotherapy, or has demonstrated clear progression after prior radiotherapy.
Key exclusion criteria (20 listed)
- Patients with leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastases (i.e., no midbrain, pons, or medulla oblongata involvement) may be enrolled if they have received local therapy, have achieved disease stability at least 2 weeks prior to the first dose of study intervention (no new brain metastases or enlargement of pre-existing brain metastatic lesions on imaging, all neurologic symptoms stabilized or returned to normal), and require no glucocorticoid treatment or receive prednisone at a daily dose ≤10 mg or equivalent doses of other glucocorticoids.
- History of other malignant neoplasms within 3 years prior to the first dose of study intervention, except for the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, etc.
- Known hypersensitivity to study drugs, any components of PD-1 inhibitors/gemcitabine/cisplatin, or humanized monoclonal antibody products.
- Prior treatment with antibody-drug conjugates (ADCs) carrying topoisomerase I inhibitor payloads.
- Adverse events from prior anti-tumor therapy that have not recovered to Grade ≤1 per NCI-CTCAE v6.0 (except for toxicities judged by the investigator to pose no safety risk such as alopecia); patients who experienced Grade ≥3 immune-related adverse events (irAEs) during prior therapy, or who permanently discontinued treatment due to irAEs
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 |
|---|---|---|
| SYS6010 combined with EnlonstobartParticipants in the experimental group will receive SYS6010, administered on Day 1 of each cycle. Participants in the experimental group will receive Enlonstobart, administered on Day 1 of each cycle. | Drug | SYS6010 combined with enlonstobart group |
| Tislelizumab combined with chemotherapyParticipants in the control group will receive: Tislelizumab :200 mg, administered by intravenous infusion on D1 every 21-day treatment cycle; Gemcitabine: 1000 mg/m², administered by intravenous infusion on D1 and 8 of each 21-day cycle; Cisplatin: 80 mg/m², administered by intravenous infusion on D1 of each 21-day cycle. | Drug | Tislelizumab+ chemotherapy |
Primary outcome
Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 37 months.
15 secondary outcomes
Overall Survival
Time frame: From date of randomization to death due to any cause, up to approximately 60 months.
ORR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: Up to approximately 24 months
DoR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: Up to approximately 37 months.
DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: Up to approximately 24 months.
PFS by the investigator based on RECIST v1.1.
Time frame: Up to approximately 37 months.
ORR by the investigator based on RECIST v1.1.
Time frame: Up to approximately 24 months.
DoR by the investigator based on RECIST v1.1.
Time frame: Up to approximately 37 months.
DCR by the investigator based on RECIST v1.1.
Time frame: Up to approximately 24 months.
Quality of life: participant head and neck cancer-specific quality of life after treatment assessed using the European Organization for Research and Treatment of Cancer Quality of Life
Time frame: Up to approximately 37 months.
Incidence of Adverse Events (AE) assessed by CTCAE 6.0.
Time frame: Up to approximately 37 months.
PK: Plasma concentration parameters (e.g., Cmax, AUC) for SYS6010 (toxin-conjugated antibody), total antibody, JS-1 and Enlonstobart.
Time frame: Up to approximately 37 months.
Serum concentrations of toxin-bound antibody of SYS6010.
Time frame: Up to approximately 37 months.
Anti-Drug Antibodies (ADA): Incidence of anti-SYS6010 antibodies.
Time frame: Up to approximately 37 months.
Anti-Drug Antibodies (ADA): Titer of anti-SYS6010 antibodies.
Time frame: Up to approximately 37 months.
Anti-Drug Antibodies (ADA): Incidence of neutralizing antibodies (if applicable).
Time frame: Up to approximately 37 months.
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 9 Nov 2026.
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.
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 SYS6010 combined with Enlonstobart and Tislelizumab combined with chemotherapy in people with Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma, run by CSPC Megalith Biopharmaceutical 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 13 inclusion and 20 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 9 Nov 2026. 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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1. (time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 37 months.). 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 9 Nov 2026.