Recurrent Nasopharyngeal CarcinomaPhase 2NCT05350891
Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC
A Phase 2 study testing endoscopic surgery in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 8 sites in China.
Trial summary
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- endoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 8 sitesChina
- Study dates
- 8 May 2022to 8 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
- AJCC rT1-T4 which can be surgically removed.
- Age ≥18 years old.
- Informed consent signed.
- With or without lymph node metastasis, which can be surgically removed.
- No distant metastasis.
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- ≥6 months from the end of initial radiotherapy to recurrence.
- Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. d) Renal function: serum creatinine ≤ 1.5 times ULN.
- ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.
Who cannot join
- Evidence of distant metastasis or leptomeningel disease (LMD).
- Have received radioactive seed implantation in the treatment area.
- Suffer from uncontrolled disease which could interfere with treatment.
- Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.).
- The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on.
- The patients have autoimmune diseases.
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- The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration.
- Severe allergic reaction to other monoclonal antibodies.
- Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment.
- Live vaccines have been inoculated within 4 weeks before the first administration or during the study period.
- The patient has any situation that may hinder study compliance or the safety during the study period.
- Existence of serious neurological or psychiatric diseases, such as dementia and seizures.
- Uncontrolled active infection.
- Pregnant or breastfeeding women.
- Those who have no personal freedom and independent capacity for civil conduct.
- There are other situations that are not suitable for entry into the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Desheng Wang, MD
Haichun Lai, MD
- Not yet recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Shaopeng Huang
Shaopeng Huang
- Not yet recruiting
The First Affiliated Hospital of USTC(University of Science and Technology of China)
Hefei, Anhui
Jingwu Sun, PhD
Jingwu Sun, PhD
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jing Ye, MD
Jing Ye
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Jingjin Weng
Shenhong Qu
- Recruiting
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Xiaole Song, 15821388769, jxfxsxl@163.com
Li Yan, 13761720601, yanl13@fudan.edu.cn
- Not yet recruiting
Shanghai Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality
Xinsheng Huang
Xinsheng Huang
- Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Yongtian Lu
Yongtian Lu
About this study
Official title: A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- endoscopic surgery
- 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
Also called adjuvant immunotherapy, chemotherapy
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| endoscopic surgery combined with adjuvant immunotherapy | Experimental | Not described Receives: Procedure: endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
2 year progression free survival
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years.
Secondary outcomes (1)
Overall survival
2 year Overall Survival rate
Measured: From date of enrollment until the date of death from any cause,through study completion,up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start8 May 2022 (estimated)
- Primary completion8 May 2026 (estimated)
- Study completion8 May 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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Hongmeng Yu, Eye & ENT Hospital of Fudan University
- Investigators
- Hongmeng Yu, MD,PHD, Principal investigator, Eye&ENT Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350891
- Sponsor's protocol ID
- rNPC-SA-Ad-Immuno-V1
- Status last verified
- May 2022
- First submitted
- 22 Mar 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05350891
- Acronym / sponsor ID
- rNPC-SA-Ad-Immuno-V1
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 8 May 2022 (estimated)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 8 May 2026 (estimated)
- First posted
- 28 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.
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for 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 |
|---|---|---|
| endoscopic surgery combined with adjuvant immunotherapy | Experimental | Procedure: endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
- AJCC rT1-T4 which can be surgically removed.
- Age ≥18 years old.
- Informed consent signed.
- With or without lymph node metastasis, which can be surgically removed.
Key exclusion criteria (16 listed)
- Evidence of distant metastasis or leptomeningel disease (LMD).
- Have received radioactive seed implantation in the treatment area.
- Suffer from uncontrolled disease which could interfere with treatment.
- Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.).
- The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on.
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 surgeryAlso: adjuvant immunotherapy, chemotherapyendoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy | Procedure or surgery | endoscopic surgery combined with adjuvant immunotherapy |
Primary outcome
progression free survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years.
2 year progression free survival
1 secondary outcome
Overall survival
Time frame: From date of enrollment until the date of death from any cause,through study completion,up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
Hongmeng Yu, MD,PHD principal investigator
Eye&ENT Hospital,Fudan University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing endoscopic surgery in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 8 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaole Song, MD (15821388769, jxfxsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 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 10 May 2022.