Recurrent Nasopharyngeal CarcinomaPhase 3NCT03907826
PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients
A Phase 3 study testing PD-1 blocking antibody, GP and IMRT in people with Recurrent Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 12 sites in China.
Trial summary
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- PD-1 blocking antibody, GP and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 12 sitesChina
- Study dates
- 1 Mar 2020to Dec 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
- Not suitable for surgery;
- Newly histologic diagnosis of NPC (WHO II/III);
- Clinical stage rII-IVa (AJCC/UICC 8th);
- ECOG 0-1 point;
- No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
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- No contraindications to immunotherapy or radiotherapy;
- 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 two months after treatment;
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- Treated with anti-tumor Chinese medicine treatment;
- Have recurrence with local necrosis;
- Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- Unexplained fever > 38.5 ℃, except for tumor fever;
- Treated with ≥ 5 days antibiotics one month before enrollment;
- 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 ≥10E4copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
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- 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;
- 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
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Peking University Third Hospital
Beijing
Suqing Tian
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu
Shun Lu
- Not yet recruiting
Fujian Province Cancer Hospital
Fuzhou
Shaojun Lin
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Chong Zhao, M.D, +86-13902206160, zhaochong@sysucc.org.cn
- Recruiting
Guizhou Cancer Hospital
Guiyang
Feng Jin
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou
Xiaozhong Chen
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang
Jingao Li
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Rengshen Wang
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai
Chaosu Hu
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Conghua Xie
- Recruiting
Xijing Hospital
Xi'an
Mei Shi
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Qin Lin
About this study
Official title: PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- PD-1 blocking antibody, GP, IMRT
- Keywords
- PD-1 antibody, Intensity-modulated Radiation Therapy, Efficacy, Adverse effect, 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.
PD-1 blocking antibodyDrug
Also called JS001
Toripalimab 240mg, D1, every 3 weeks per cycle
GPDrug
Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
IMRTRadiation
IMRT 60-66Gy, 1.8-2.0Gy/f/day
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody plus chemoradiotherapy | Experimental | Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles. Receives: Drug: PD-1 blocking antibody; Drug: GP; Radiation: IMRT |
| Chemoradiotherapy | Active comparator | Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone. Receives: Drug: GP; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From date of randomisation to death
Measured: 3 years
Secondary outcomes (4)
Progression free survival
From date of randomisation to disease progression
Measured: 3 years
Short-term effects
Patient's objective response rate
Measured: through study completion, an average of 2 months
Rate of patients with acute toxicities
Evaluating with CTCAE v5.0
Measured: through study completion, an average of 2 months
Quality of life: EuroQoL 5 dimension
Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Measured: through whole study, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Mar 2020
- 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 Recurrent 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
- 212 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, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907826
- Sponsor's protocol ID
- rNPC-JS001
- Status last verified
- May 2026
- First submitted
- 5 Apr 2019
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT03907826
- Acronym / sponsor ID
- rNPC-JS001
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- PD-1 antibody, Intensity-modulated Radiation Therapy, Efficacy, Adverse effect, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Apr 2019 (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, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody plus chemoradiotherapy | Experimental | Drug: PD-1 blocking antibody, Drug: GP, Radiation: IMRTPatients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles. |
| Chemoradiotherapy | Active comparator | Drug: GP, Radiation: IMRTPatients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
- Not suitable for surgery;
- Newly histologic diagnosis of NPC (WHO II/III);
- Clinical stage rII-IVa (AJCC/UICC 8th);
- ECOG 0-1 point;
Key exclusion criteria (12 listed)
- Treated with anti-tumor Chinese medicine treatment;
- Have recurrence with local necrosis;
- Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- Unexplained fever > 38.5 ℃, except for tumor fever;
- Treated with ≥ 5 days antibiotics one month before enrollment;
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 blocking antibodyAlso: JS001Toripalimab 240mg, D1, every 3 weeks per cycle | Drug | PD-1 antibody plus chemoradiotherapy |
| GPGemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles | Drug | Chemoradiotherapy, PD-1 antibody plus chemoradiotherapy |
| IMRTIMRT 60-66Gy, 1.8-2.0Gy/f/day | Radiation | Chemoradiotherapy, PD-1 antibody plus chemoradiotherapy |
Primary outcome
Overall survival
Time frame: 3 years
From date of randomisation to death
4 secondary outcomes
Progression free survival
Time frame: 3 years
Short-term effects
Time frame: through study completion, an average of 2 months
Rate of patients with acute toxicities
Time frame: through study completion, an average of 2 months
Quality of life: EuroQoL 5 dimension
Time frame: through whole study, an average of 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 7 May 2026.
- Home Page of Sun Yat-sen University Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Sun Yat-Sen University Cancer Center
12 sites 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 blocking antibody, GP and IMRT in people with Recurrent Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 12 sites 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 12 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 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 12 sites 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 Jingjing Miao (02087342638, miaojingjing90@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 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 7 May 2026.