Nasopharyngeal CarcinomaPhase 2NCT06323239
SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
A Phase 2 study testing SBRT, Low-dose Radiotherapy (LDRT) and Toripalimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients. 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, Low-dose Radiotherapy (LDRT) and Toripalimab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to Dec 2028
- 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 recurrence/metastatic NPC
- Histopathological diagnosis of NPC(WHO II/III)
- ECOG 0-1 point
- No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy and chemoradiotherapy;
- At least one lesion 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 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;
- Pregnant or breastfeeding;
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- 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. 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
Chong Zhao, M.D, 02087342638, zhaochong@sysucc.org.cn
Jingjing Miao, M.D., 13631355201, miaojj@sysucc.org.cn
About this study
Official title: Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- SBRT, Low-dose Radiotherapy (LDRT), Toripalimab, Gemcitabine, Cisplatin
- Keywords
- SBRT, Low-dose radiotherapy, PD-1 antibody, Chemotherapy
- 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
Low-dose Radiotherapy (LDRT)Radiation
LDRT for metastatic lesions
ToripalimabDrug
6 cycles for combined therapy. Toripalimab maintenance for 1 year.
GemcitabineDrug
6 cycles for combined therapy.
CisplatinDrug
6 cycles for combined therapy.
IMRTRadiation
IMRT for primary lesion
| Study group | Role | What they receive |
|---|---|---|
| SBRT+LDRT+PD-1+Chemotherapy | Experimental | Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment. Receives: Radiation: SBRT; Radiation: Low-dose Radiotherapy (LDRT); Drug: Toripalimab; Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT |
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 posted21 Mar 2024
- Study start15 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
- Investigators
- Chong Zhao, MD. PhD., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323239
- Sponsor's protocol ID
- SBRT/LDRT+PD-1+GP for r/mNPC
- Status last verified
- May 2026
- First submitted
- 14 Mar 2024
- Last updated
- 11 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06323239
- Acronym / sponsor ID
- SBRT/LDRT+PD-1+GP for r/mNPC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- SBRT, Low-dose radiotherapy, PD-1 antibody, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Mar 2024 (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, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+LDRT+PD-1+Chemotherapy | Experimental | Radiation: SBRT, Radiation: Low-dose Radiotherapy (LDRT), Drug: Toripalimab, Drug: Gemcitabine, Drug: Cisplatin, Radiation: IMRTPatients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 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 recurrence/metastatic NPC
- Histopathological diagnosis of NPC(WHO II/III)
- ECOG 0-1 point
- No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy and chemoradiotherapy;
Key exclusion criteria (9 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 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;
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+LDRT+PD-1+Chemotherapy |
| Low-dose Radiotherapy (LDRT)LDRT for metastatic lesions | Radiation | SBRT+LDRT+PD-1+Chemotherapy |
| Toripalimab6 cycles for combined therapy. Toripalimab maintenance for 1 year. | Drug | SBRT+LDRT+PD-1+Chemotherapy |
| Gemcitabine6 cycles for combined therapy. | Drug | SBRT+LDRT+PD-1+Chemotherapy |
| Cisplatin6 cycles for combined therapy. | Drug | SBRT+LDRT+PD-1+Chemotherapy |
| IMRTIMRT for primary lesion | Radiation | SBRT+LDRT+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 11 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.
Chong Zhao, MD. PhD. principal investigator
Sun Yat-sen University
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, Low-dose Radiotherapy (LDRT) and Toripalimab 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 9 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 11 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?
Contact Jingjing Miao, MD. (13631355201, miaojj@sysucc.org.cn), or a site near the patient. 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 11 May 2026.