Nasopharyngeal CarcinomaPhase 3NCT05340491
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
A Phase 3 study testing Toripalimab, Chemotherapy and Intensity modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 12 sites in China.
Trial summary
This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined 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
- Nasopharyngeal Carcinoma
- What is being tested?
- Toripalimab, Chemotherapy and Intensity modulated radiotherapy
- 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 Apr 2022to 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 with or without regional recurrence after ≥1 year of radical treatment;
- Not suitable for surgery;
- Histologic diagnosis of NPC (WHO II/III);
- TNM stage rII-IVa (AJCC/UICC 8th);
- ECOG 0-1 point;
- No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
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- 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
- 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 ≥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;
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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
- 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, 510060
Jingjing Miao, PhD, 13631355201, miaojj@sysucc.org.cn
Chong Zhao, MD PhD
- Not yet recruiting
Guizhou Cancer Hospital
Guiyang
Feng Jin
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Xiaozhong Chen
- 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: Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Toripalimab, Chemotherapy, Intensity modulated radiotherapy
- Keywords
- locoregional relapse, nasopharyngeal carcinoma, chemoradiotherapy, PD-1 antibody, efficacy, toxicity
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called JS001
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
ChemotherapyDrug
Also called GP
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Intensity modulated radiotherapyRadiation
Also called IMRT
total 60-66Gy, 1.8-2.0Gy/f/day
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy+anti-PD-1 | Experimental | Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles. Receives: Drug: Toripalimab; Drug: Chemotherapy; Radiation: Intensity modulated radiotherapy |
| Chemoradiotherapy | Active comparator | Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT. Receives: Drug: Chemotherapy; Radiation: Intensity modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Defined as the time from date of recruitment to death from any cause.
Measured: three years
Secondary outcomes (7)
Failure-free survival
Defined as the time from date of recruitment to documented relapse or death from any cause.
Measured: three years
Objective response rate through study completion, an average of nine months
The rate of patients get CR or PR after treatment
Measured: through study completion, an average of nine months
Disease control rate through study completion, an average of nine months
The rate of patients get CR or PR or SD after treatment
Measured: through study completion, an average of nine months
Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years
Incidence of nasopharyngeal necrosis and hemorrhage after receiving treatment
Measured: up to three-year follow-up
Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) for chemotherapy and immunotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.
Measured: through study completion, an average of nine months
Late toxicity
Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.
Measured: three years
Quality of life through study completion, up to 3 years
Evaluated with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L).
Measured: up to three-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Apr 2022
- 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 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, MD PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340491
- Sponsor's protocol ID
- B2022-111-01
- Status last verified
- May 2026
- First submitted
- 9 Apr 2022
- Last updated
- 11 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
- ClinicalTrials.gov ID
- NCT05340491
- Acronym / sponsor ID
- B2022-111-01
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- locoregional relapse, nasopharyngeal carcinoma, chemoradiotherapy, PD-1 antibody, efficacy, toxicity
- 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 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Apr 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, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined 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 |
|---|---|---|
| Chemoradiotherapy+anti-PD-1 | Experimental | Drug: Toripalimab, Drug: Chemotherapy, Radiation: Intensity modulated radiotherapyPatients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles. |
| Chemoradiotherapy | Active comparator | Drug: Chemotherapy, Radiation: Intensity modulated radiotherapyPatients in this arm will receive three cycles of GP chemotherapy, then receive IMRT. |
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 with or without regional recurrence after ≥1 year of radical treatment;
- Not suitable for surgery;
- Histologic diagnosis of NPC (WHO II/III);
- TNM 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 |
|---|---|---|
| ToripalimabAlso: JS001240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT | Drug | Chemoradiotherapy+anti-PD-1 |
| ChemotherapyAlso: GPGemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles | Drug | Chemoradiotherapy, Chemoradiotherapy+anti-PD-1 |
| Intensity modulated radiotherapyAlso: IMRTtotal 60-66Gy, 1.8-2.0Gy/f/day | Radiation | Chemoradiotherapy, Chemoradiotherapy+anti-PD-1 |
Primary outcome
Overall survival
Time frame: three years
Defined as the time from date of recruitment to death from any cause.
7 secondary outcomes
Failure-free survival
Time frame: three years
Objective response rate through study completion, an average of nine months
Time frame: through study completion, an average of nine months
Disease control rate through study completion, an average of nine months
Time frame: through study completion, an average of nine months
Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years
Time frame: up to three-year follow-up
Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Time frame: through study completion, an average of nine months
Late toxicity
Time frame: three years
Quality of life through study completion, up to 3 years
Time frame: up to three-year follow-up
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: Undecided
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Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
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Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma
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Not yet recruitingPhase 2
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
Not yet recruitingPhase 2
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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 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 Toripalimab, Chemotherapy and Intensity modulated radiotherapy in people with 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 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 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, PhD (+8613631355201, miaojj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: three 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.