Recurrent Nasopharyngeal CarcinomaPhase 3NCT06228079
Adjuvant vs Surgery Only in Early-stage Recurrent NPC
A Phase 3 study testing Immunotherapy,Toripalimab Injection and Chemotherapy,Gemcitabine based regimen in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 7 sites in China.
Trial summary
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- Immunotherapy,Toripalimab Injection and Chemotherapy,Gemcitabine based regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 7 sitesChina
- Study dates
- 25 Jun 2024to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
- Cervical lymph node metastasis can be controlled locally
- Age 18 to 75 years;
- Without distant metastasis;
- Informed consent forms signed;
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- ≥6months from the accomplishment of radiation to recurrence
- previously radiotherapy for only 1 course;
- ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
- Sufficient organ function;
- Undergone endoscopic surgery with negative pathological margin;
Who cannot join
- Participation in other interventional clinical trials;
- Uncontrolled illnesses which will interfere with the ability to undergo therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
- Any contradiction to immune and chemotherapy;
- With serious autoimmune disease;
- Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
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- Severe allergic reactions to other monoclonal antibodies;
- History of radioactive particle planting;
- Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
- Female patients who are at pregnancy or lactation;
- Other situations that the researchers believe are not suitable for enrollment
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yuting Lai contact
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou
Desheng Wang
Desheng Wang
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
Shenhong Qu
Shenhong Qu
- Recruiting
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Xiaole Song, 15821388769, jxfxsxl@163.com
Hongmeng Yu
- Recruiting
Changhai Hospital
Shanghai
Haihong Tang
Haihong Tang
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai
Weitian Zhang
Weitian Zhang
- Not yet recruiting
Shanghai Zhongshan Hospital
Shanghai
Xinsheng Huang
Xinsheng Huang
- Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen
Yongtian Lu
Yongtian Lu
About this study
Official title: Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Read the detailed description
This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.
Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- Immunotherapy,Toripalimab Injection, Chemotherapy,Gemcitabine based regimen
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy,Toripalimab InjectionDrug
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Chemotherapy,Gemcitabine based regimenDrug
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery. |
| The experimental group | Experimental | Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery. Receives: Drug: Immunotherapy,Toripalimab Injection; Drug: Chemotherapy,Gemcitabine based regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease free survival
Measured: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (5)
OS
Overall Survival
Measured: From randomization to death of any cause,assessed up to 60 months
LRFS
Local recurrence free survival
Measured: From randomization to local recurrence or death,assessed up to 24 months
DMFS
Distant metastasis free survival
Measured: From randomization to distant metastasis or death, assessed up to 24 months
1-and 2-year DFS rate
one- and two-year disease free survival
Measured: end of 1st year, end of 2nd year
1-and 2-year OS rate
one- and two-year overall survival rate
Measured: end of 1st year, end of 2nd year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start25 Jun 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 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 Eye & ENT Hospital of Fudan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai 6th People's Hospital, Changhai Hospital, Fujian Medical University Union Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Shenzhen Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- Hongmeng Yu, Principal investigator, Eye& ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228079
- Sponsor's protocol ID
- early-rNPC-RCT-adj
- Status last verified
- Jul 2025
- First submitted
- 21 Dec 2023
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06228079
- Acronym / sponsor ID
- early-rNPC-RCT-adj
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai 6th People's Hospital, Changhai Hospital, Fujian Medical University Union Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Shenzhen Second People's Hospital
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Jan 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.
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Detailed description
This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.
Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery. |
| The experimental group | Experimental | Drug: Immunotherapy,Toripalimab Injection, Drug: Chemotherapy,Gemcitabine based regimenPatients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
- Cervical lymph node metastasis can be controlled locally
- Age 18 to 75 years;
- Without distant metastasis;
Key exclusion criteria (11 listed)
- Participation in other interventional clinical trials;
- Uncontrolled illnesses which will interfere with the ability to undergo therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
- Any contradiction to immune and chemotherapy;
- With serious autoimmune disease;
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 |
|---|---|---|
| Immunotherapy,Toripalimab InjectionPatients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects. | Drug | The experimental group |
| Chemotherapy,Gemcitabine based regimenPatients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects. | Drug | The experimental group |
Primary outcome
DFS
Time frame: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
Disease free survival
5 secondary outcomes
OS
Time frame: From randomization to death of any cause,assessed up to 60 months
LRFS
Time frame: From randomization to local recurrence or death,assessed up to 24 months
DMFS
Time frame: From randomization to distant metastasis or death, assessed up to 24 months
1-and 2-year DFS rate
Time frame: end of 1st year, end of 2nd year
1-and 2-year OS rate
Time frame: end of 1st year, end of 2nd year
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 4 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
Yuting Lai contact
Hongmeng Yu principal investigator
Eye& ENT Hospital, Fudan University
7 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 Immunotherapy,Toripalimab Injection and Chemotherapy,Gemcitabine based regimen in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 7 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 11 inclusion and 11 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Xiaole Song, MD (+8621 64377134, jxfxsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 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 4 Jul 2025.