Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma
Study Details
Study Description
Brief Summary
To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Camrelizumab and chemotherapy combined with endoscopic surgery Camrelizumab and chemotherapy combined with endoscopic surgery |
Drug: Camrelizumab
2 cycles before endoscopic surgery and one year after
Drug: Chemotherapy
2 cycles before endoscopic surgery, with or without after surgery
Procedure: endoscopic surgery
standard endoscopic surgery for recurrent nasopharyngeal carcinoma
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [From date of first treatment until the date of death from any cause, up to 4 years.]
2 year Overall Survival rate
Secondary Outcome Measures
- Local recurrence free survival [From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.]
the date of first treatment to local failure or death
- Progression free survival [From date of first treatment until the date of disease progression or death from any cause, up to 4 years.]
the date of first treatment to the first recording of disease progression or death from any cause.
- Rate of negative margin [At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.]
negative margin rate according to pathology report
- distant metastasis free survival [From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.]
the date of first treatment to distant metastasis or death
- pathologic complete remission [At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.]
pathologic complete remission
Other Outcome Measures
- quality of life-（EORTC QLQ) - C30 version3.0 [From date of first treatment to the end of study, at each visit, up to 4 years.]
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
- quality of life-（EORTC QLQ) - H&N35 [From date of first treatment to the end of study, at each visit, up to 4 years.]
using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems.
- adverse effect [From date of first treatment to the end of study, up to 4 years.]
Using CTCAE Version5.0 to evaluate related adverse effect
- immune related adverse effect [From date of first treatment to the end of study, up to 4 years.]
Using CTCAE Version5.0 to evaluate immune related adverse effect
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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With or without lymph node metastasis, which can be surgically removed
-
No massive hemorrhage risk recently
-
No distant metastasis
-
≥6 months from initial radiotherapy to recurrence
-
Radical radiation only once
-
Sufficient organ function
-
Eastern Cooperative Oncology Group score 0-2
Exclusion Criteria:
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With a history of allergic to platinum drugs and similar compounds
-
Evidence of distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD)
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Have received radioactive seed implantation in the treatment area
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Suffer from uncontrolled disease which could interfere with treatment
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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.)
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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
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Severe allergic reaction to other monoclonal antibodies
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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
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Live vaccines have been inoculated within 4 weeks before the first administration or during the study period
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The patient has any situation that may hinder study compliance or the safety during the study period
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Existence of serious neurological or psychiatric diseases, such as dementia and seizures
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Uncontrolled active infection
-
Pregnant or breastfeeding women
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Those who have no personal freedom and independent capacity for civil conduct
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There are other situations that are not suitable for entry into the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Medical University Union Hospital | Fuzhou | Fujian | China | |
| 2 | Fujian Provincial Hospital | Fuzhou | Fujian | China | |
| 3 | Shenzhen Second People's Hospital | Shenzhen | Guangdong | China | |
| 4 | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China | |
| 5 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | |
| 6 | Eye& ENT Hospital, Fudan University | Shanghai | Shanghai | China | 200031 |
| 7 | Shanghai Zhongshan Hospital,Fudan University | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
- Chinese Academy of Medical Sciences
Investigators
- Principal Investigator: Hongmeng Yu, MD,PHD, Eye&ENT Hospital,Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rNPC-SA-Neo-Cam-V1