Recurrent Nasopharyngeal CarcinomaPhase 2NCT05011227
Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Camrelizumab, Chemotherapy and endoscopic surgery in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 7 sites in China.
Trial summary
To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of 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?
- Camrelizumab, Chemotherapy and endoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesChina
- Study dates
- 10 Aug 2021to 10 Aug 2025
- 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
- Pathologically confirmed recurrent nasopharyngeal carcinoma
- American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent 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 massive hemorrhage risk recently
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- No distant metastasis
- ≥6 months from initial radiotherapy to recurrence
- Radical radiation only once
- Sufficient organ function
- Eastern Cooperative Oncology Group score 0-2
Who cannot join
- With a history of allergic to platinum drugs and similar compounds
- Evidence of distant metastasis or radiation encephalopathy or leptomeningeal 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
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- The patients have autoimmune diseases
- 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
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 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 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, PhD
Shenhong Qu
- Recruiting
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Li Yan, MD, 13761720601, yanl13@fudan.edu.cn
Xiaoshen Wang, PHD
- 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, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma
To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- Camrelizumab, Chemotherapy, endoscopic surgery
- Keywords
- endoscopic surgery, Inductive chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
2 cycles Camrelizumab before endoscopic surgery and one year after
ChemotherapyDrug
2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery
endoscopic surgeryProcedure or surgery
standard endoscopic surgery for recurrent nasopharyngeal carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab and chemotherapy combined with endoscopic surgery | Experimental | Camrelizumab and chemotherapy combined with endoscopic surgery Receives: Drug: Camrelizumab; Drug: Chemotherapy; Procedure: endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
2 year Overall Survival rate
Measured: From date of first treatment until the date of death from any cause, up to 4 years.
Secondary outcomes (5)
Local recurrence free survival
the date of first treatment to local failure or death
Measured: From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
Progression free survival
the date of first treatment to the first recording of disease progression or death from any cause.
Measured: From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
Rate of negative margin
negative margin rate according to pathology report
Measured: At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
distant metastasis free survival
the date of first treatment to distant metastasis or death
Measured: From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
pathologic complete remission
pathologic complete remission
Measured: At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Aug 2021
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Aug 2025 (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
- 100 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
- Sponsor
- Investigators
- Hongmeng Yu, MD,PHD, Principal investigator, Eye&ENT Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011227
- Sponsor's protocol ID
- rNPC-SA-Neo-Cam-V1
- Status last verified
- Mar 2024
- First submitted
- 7 Aug 2021
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05011227
- Acronym / sponsor ID
- rNPC-SA-Neo-Cam-V1
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- endoscopic surgery, Inductive chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 18 Aug 2021 (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.
To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of 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 |
|---|---|---|
| Camrelizumab and chemotherapy combined with endoscopic surgery | Experimental | Drug: Camrelizumab, Drug: Chemotherapy, Procedure: endoscopic surgeryCamrelizumab and chemotherapy combined with endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed recurrent nasopharyngeal carcinoma
- American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent 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 (17 listed)
- With a history of allergic to platinum drugs and similar compounds
- Evidence of distant metastasis or radiation encephalopathy or leptomeningeal 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.)
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 |
|---|---|---|
| Camrelizumab2 cycles Camrelizumab before endoscopic surgery and one year after | Drug | Camrelizumab and chemotherapy combined with endoscopic surgery |
| Chemotherapy2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery | Drug | Camrelizumab and chemotherapy combined with endoscopic surgery |
| endoscopic surgerystandard endoscopic surgery for recurrent nasopharyngeal carcinoma | Procedure or surgery | Camrelizumab and chemotherapy combined with endoscopic surgery |
Primary outcome
Overall Survival
Time frame: From date of first treatment until the date of death from any cause, up to 4 years.
2 year Overall Survival rate
5 secondary outcomes
Local recurrence free survival
Time frame: From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
Progression free survival
Time frame: From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
Rate of negative margin
Time frame: At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
distant metastasis free survival
Time frame: From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
pathologic complete remission
Time frame: At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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. This study is not recruiting at the moment.
Hongmeng Yu, MD,PHD 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 2 study testing Camrelizumab, Chemotherapy and endoscopic surgery 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 17 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 6 Mar 2024. 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 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?
Overall Survival (time frame: From date of first treatment until the date of death from any cause, up to 4 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 6 Mar 2024.