Recurrent Nasopharyngeal CarcinomaPhase 3NCT06235203
Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
A Phase 3 study testing endoscopic surgery, Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy and Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 7 sites in China.
Trial summary
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy 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?
- endoscopic surgery, Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy and Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 7 sitesChina
- Study dates
- 9 Jul 2024to 30 Jun 2027
- 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;
- Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
- Cervical lymph node metastasis can be controlled locally;
- Aged 18 to 75 years;
- Informed consent forms signed to participate in the trial;
- Without distant metastasis;
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- ≥6months from the accomplishment of radical radiation to recurrence
- previously only 1 course of radiotherapy;
- Sufficient organ function;
- ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.
Who cannot join
- Participate in other interventional clinical trials;
- Uncontrolled illnesses that interfere with the therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
- Any contradiction to surgery;
- With serious autoimmune disease;
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
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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 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.
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
- Not yet 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: Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
Read the detailed description
Eligible patients are randomized into the control group and the experimental group.
Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.
Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- endoscopic surgery, Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy, Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy, Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
The tumor was resected by endoscopic nasopharyngectomy.
Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapyDrug
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapyDrug
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapyDrug
Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | Endoscopic surgery + adjuvant therapy Receives: Procedure: endoscopic surgery; Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy |
| The experimental group | Experimental | Neoadjuvant therapy +endoscopic surgery + adjuvant therapy Receives: Procedure: endoscopic surgery; Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy; Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS
Event free survival
Measured: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
Secondary outcomes (10)
OS
Overall Survival
Measured: Time interval of randomization and death of any cause, up to 5 years
DFS
Disease free survival
Measured: From randomization to recurrence, metastasis or death, up to 1 year
LRFS
Local recurrence free survival
Measured: From randomization to local recurrence or death, up to 1 year
DMFS
Distant metastasis free survival
Measured: From randomization to distant metastasis or death, up to 1 year
pCR
pathologic complete response
Measured: Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery
ORR
Objective response rate,Proportion of CR, PR in all patients.
Measured: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
DCR
Disease Control Rate,Proportion of CR, PR and SD in all patients.
Measured: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
DoR
Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).
Measured: First date of response to the date of progression, up to 5 years
1-and 2-year PFS rate
one- and two-year progression free survival rate
Measured: one- and two-year
1-and 2-year OS rate
one- and two-year overall survival rate
Measured: one- and two-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start9 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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.
- 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
- 154 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235203
- Sponsor's protocol ID
- adv-rNPC-RCT-Neo-V1
- Status last verified
- May 2025
- First submitted
- 21 Dec 2023
- Last updated
- 3 Jun 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06235203
- Acronym / sponsor ID
- adv-rNPC-RCT-Neo-V1
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 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
- 9 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 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.
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
Detailed description
Eligible patients are randomized into the control group and the experimental group.
Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.
Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.
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 | Active comparator | Procedure: endoscopic surgery, Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapyEndoscopic surgery + adjuvant therapy |
| The experimental group | Experimental | Procedure: endoscopic surgery, Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy, Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapyNeoadjuvant therapy +endoscopic surgery + adjuvant therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
- Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
- Cervical lymph node metastasis can be controlled locally;
- Aged 18 to 75 years;
- Informed consent forms signed to participate in the trial;
Key exclusion criteria (11 listed)
- Participate in other interventional clinical trials;
- Uncontrolled illnesses that interfere with the therapy;
- Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
- Any contradiction to surgery;
- 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 |
|---|---|---|
| endoscopic surgeryThe tumor was resected by endoscopic nasopharyngectomy. | Procedure or surgery | The control group, The experimental group |
| Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapyTwo courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery. | Drug | The experimental group |
| Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapyEight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects. | Drug | The experimental group |
| Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapyTen courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects. | Drug | The control group |
Primary outcome
EFS
Time frame: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
Event free survival
10 secondary outcomes
OS
Time frame: Time interval of randomization and death of any cause, up to 5 years
DFS
Time frame: From randomization to recurrence, metastasis or death, up to 1 year
LRFS
Time frame: From randomization to local recurrence or death, up to 1 year
DMFS
Time frame: From randomization to distant metastasis or death, up to 1 year
pCR
Time frame: Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery
ORR
Time frame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
DCR
Time frame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
DoR
Time frame: First date of response to the date of progression, up to 5 years
1-and 2-year PFS rate
Time frame: one- and two-year
1-and 2-year OS rate
Time frame: one- and two-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 3 Jun 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.
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 endoscopic surgery, Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy and Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy 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 10 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 3 Jun 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 (+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?
EFS (time frame: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year). 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 3 Jun 2025.