Recurrent Nasopharyngeal CarcinomaPhase 2NCT03930498
Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing PD-1 blocking antibody, Chemotherapy and IMRT in people with Recurrent Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- PD-1 blocking antibody, Chemotherapy and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2020to May 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 65 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;
- PRANCIS score > 252 points;
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- No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy or chemoradiotherapy;
- 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
- 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 ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
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- 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;
- 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: PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial
This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- PD-1 blocking antibody, Chemotherapy, IMRT
- Keywords
- PD-1 antibody, Intensity-modulated Radiation Therapy, Chemotherapy, Efficacy, Adverse effects
- 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 is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
ChemotherapyDrug
Cisplatin and Gemcitabine
IMRTRadiation
IMRT 60-66Gy, 1.8-2.0Gy/f/day
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody plus chemoradiotherapy | Experimental | Not described Receives: Drug: PD-1 blocking antibody; Drug: Chemotherapy; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From date of recruitment to death
Measured: 2 years
Secondary outcomes (5)
Objective response rate
Patient's short-term effect
Measured: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Disease control rate
Patient's short-term effect
Measured: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Progression free survival
From date of recruitment to disease progression or death
Measured: 2 years
Adverse effects
Evaluating with CTCAE v5.0
Measured: through study completion, an average of 3 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 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start12 Mar 2020
- Primary completion22 Nov 2023
- Study completionMay 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 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, M.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930498
- Sponsor's protocol ID
- High-risk rNPC-JS001
- Status last verified
- May 2026
- First submitted
- 25 Apr 2019
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03930498
- Acronym / sponsor ID
- High-risk rNPC-JS001
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- PD-1 antibody, Intensity-modulated Radiation Therapy, Chemotherapy, Efficacy, Adverse effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 29 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 a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody plus chemoradiotherapy | Experimental | Drug: PD-1 blocking antibody, Drug: Chemotherapy, Radiation: IMRT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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 (13 listed)
- 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);
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 is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd. | Drug | PD-1 antibody plus chemoradiotherapy |
| ChemotherapyCisplatin and Gemcitabine | Drug | PD-1 antibody plus chemoradiotherapy |
| IMRTIMRT 60-66Gy, 1.8-2.0Gy/f/day | Radiation | PD-1 antibody plus chemoradiotherapy |
Primary outcome
Overall survival
Time frame: 2 years
From date of recruitment to death
5 secondary outcomes
Objective response rate
Time frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Disease control rate
Time frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Progression free survival
Time frame: 2 years
Adverse effects
Time frame: through study completion, an average of 3 months
Quality of life: EuroQoL 5 dimension
Time frame: through whole study, an average of 2 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 11 May 2026.
- Home Page of Sun Yat-sen University Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, M.D 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 PD-1 blocking antibody, Chemotherapy and IMRT in people with Recurrent 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 13 inclusion and 13 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 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?
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?
Overall survival (time frame: 2 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 11 May 2026.