Nasopharyngeal CarcinomaPhase 2NCT05524168
SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma
A Phase 2 study testing SBRT, Camrelizumab and Gemcitabine in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis. 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?
- SBRT, Camrelizumab and Gemcitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2022to Dec 2026
- Phase
- Phase 2
- 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
- Diagnosed as metastatic NPC with no more than 5 metastatic lesions;
- Histopathological diagnosis of NPC;
- ECOG 0-1 point;
- Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy and chemoradiotherapy;
- Every metastatic lesions could receive SBRT safely;
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- Subject must have a measurable target lesion based on RECIST v1.1;
- Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
- Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
- Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Take effective contraceptions during and three months after treatment;
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
- Unexplained fever > 38.5 ℃, except for tumor fever;
- Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
- Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
- Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy;
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- Pregnant or breastfeeding;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
- Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SBRT Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Nasopharyngeal Carcinoma With Oligometastasis: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial
This is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- SBRT, Camrelizumab, Gemcitabine, Cisplatin
- Keywords
- SBRT, PD-1 antibody, Chemotherapy, Efficacy, Safety, Oligometastasis
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
SBRT for metastatic lesions
CamrelizumabDrug
Also called SHR-1210
Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.
GemcitabineDrug
Maximum 6 cycles for combined therapy.
CisplatinDrug
Maximum 6 cycles for combined therapy.
| Study group | Role | What they receive |
|---|---|---|
| SBRT+PD-1+Chemotherapy | Experimental | Patients will receive SBRT first, then PD-1 antibody (Camrelizumab 200mg/Q3W) and chemotherapy (cisplatin 80mg/m2 on d1, gemcitabine 1000mg/m2, d1 and d8, Q3W, maximum 6 cycles), followed by Camrelizumab (200mg/Q3W) until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 1 year treatment. Receives: Radiation: SBRT; Drug: Camrelizumab; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: up to 12 months
Secondary outcomes (5)
Overall Survival
Defined as the time from randomization to death from any cause.
Measured: up to 12 months
Objective Response Rate
The percentage of patients with CR and PR assessed according to RECIST v1.1.
Measured: up to 12 months
Disease Control Rate
The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.
Measured: up to 12 months
Adverse Events
All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03
Measured: up to 12 months
QoL
Assessed by EQ-5D-5L questionnaire
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start25 Nov 2022
- Primary completion6 Jun 2025
- Study completionDec 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen People's Hospital, First People's Hospital of Foshan, Jiangxi Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, Chongqing University Cancer Hospital
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
- Investigators
- Chong Zhao, MD. PhD., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524168
- Sponsor's protocol ID
- SBRT+PD-1+Chemo for mNPC
- Status last verified
- May 2026
- First submitted
- 29 Aug 2022
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Nasopharyngeal Carcinoma With Oligometastasis: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT05524168
- Acronym / sponsor ID
- SBRT+PD-1+Chemo for mNPC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- SBRT, PD-1 antibody, Chemotherapy, Efficacy, Safety, Oligometastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen People's Hospital, First People's Hospital of Foshan, Jiangxi Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, Chongqing University Cancer Hospital
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Sep 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 is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+PD-1+Chemotherapy | Experimental | Radiation: SBRT, Drug: Camrelizumab, Drug: Gemcitabine, Drug: CisplatinPatients will receive SBRT first, then PD-1 antibody (Camrelizumab 200mg/Q3W) and chemotherapy (cisplatin 80mg/m2 on d1, gemcitabine 1000mg/m2, d1 and d8, Q3W, maximum 6 cycles), followed by Camrelizumab (200mg/Q3W) until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 1 year treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosed as metastatic NPC with no more than 5 metastatic lesions;
- Histopathological diagnosis of NPC;
- ECOG 0-1 point;
- Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy and chemoradiotherapy;
Key exclusion criteria (10 listed)
- Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
- Unexplained fever > 38.5 ℃, except for tumor fever;
- Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
- Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
- Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
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 |
|---|---|---|
| SBRTSBRT for metastatic lesions | Radiation | SBRT+PD-1+Chemotherapy |
| CamrelizumabAlso: SHR-1210Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year. | Drug | SBRT+PD-1+Chemotherapy |
| GemcitabineMaximum 6 cycles for combined therapy. | Drug | SBRT+PD-1+Chemotherapy |
| CisplatinMaximum 6 cycles for combined therapy. | Drug | SBRT+PD-1+Chemotherapy |
Primary outcome
Progression-free survival
Time frame: up to 12 months
Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
5 secondary outcomes
Overall Survival
Time frame: up to 12 months
Objective Response Rate
Time frame: up to 12 months
Disease Control Rate
Time frame: up to 12 months
Adverse Events
Time frame: up to 12 months
QoL
Time frame: up to 12 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 7 May 2026.
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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.
Chong Zhao, MD. PhD. principal investigator
Sun Yat-Sen University Cancer Center
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 SBRT, Camrelizumab and Gemcitabine 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 12 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 May 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 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?
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?
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?
Progression-free survival (time frame: up to 12 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 7 May 2026.