| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Drug: PD-1 blocking antibody Drug: Chemotherapy Radiation: IMRT | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 43 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial |
| Actual Study Start Date : | March 1, 2020 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: PD-1 antibody plus chemoradiotherapy |
Drug: PD-1 blocking antibody
Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
Other Name: JS001
Drug: Chemotherapy Cisplatin and Gemcitabine
Radiation: IMRT IMRT 60-66Gy, 1.8-2.0Gy/f/day
|
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Jingjing Miao, M.D | 02087342638 | miaojj1@sysucc.org.cn |
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Chong Zhao, M.D +86-13902206160 zhaochong@sysucc.org.cn | |
| Contact: Jingjing Miao, M.D 02087342638 miaojj@sysucc.org.cn | |
| Principal Investigator: | Chong Zhao, M.D | Sun Yat-sen University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||
| First Posted Date ICMJE | April 29, 2019 | ||||
| Last Update Posted Date | June 7, 2021 | ||||
| Actual Study Start Date ICMJE | March 1, 2020 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Objective response rate [ Time Frame: After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days) ] Patient's short-term effect
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma | ||||
| Official Title ICMJE | PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial | ||||
| Brief Summary | This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Recurrent Nasopharyngeal Carcinoma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: PD-1 antibody plus chemoradiotherapy
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
43 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2023 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03930498 | ||||
| Other Study ID Numbers ICMJE | High-risk rNPC-JS001 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Zhao Chong, Sun Yat-sen University | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Sun Yat-sen University | ||||
| Verification Date | June 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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