Condition or disease | Intervention/treatment | Phase |
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Small Cell Carcinoma of Esophagus Advanced Cancer | Drug: Toripalimab | 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: | Phase II Clinical Trial of Toripalimab (JS001), a Recombinant Humanized Anti-PD-1 Monoclonal PD1 Antibody, as Monotherapy for Patients With Small Cell Esophageal Carcinoma Who Failed Chemotherapy |
Actual Study Start Date : | November 21, 2018 |
Estimated Primary Completion Date : | December 30, 2020 |
Estimated Study Completion Date : | December 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Toripalimab
Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
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Drug: Toripalimab
Drug: Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The toxicity of previous antineoplastic therapies has not been restored to CTCAE 0-1, except for the following cases:
A alopecia; B pigmentation; C Peripheral neurotoxicity has been restored to < CTCAE level 2. D The long-term toxicity caused by radiotherapy can not be restored by the judgement of the researchers.
(1) heart failure above NYHA Level 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention;
Contact: Feng Wang, MD, PhD | +8602087342635 | lvzd@sysucc.org.cn |
China, Guangdong | |
Cancer center of Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Rui-Hua Xu, MD, PhD +862087342635 lvzd@sysucc.org.cn | |
Principal Investigator: Rui-hua Xu, MD, PhD | |
Sub-Investigator: Feng Wang, MD, PhD |
Principal Investigator: | Rui-hua Xu, MD, PhD | Sun Yat-sen University |
Tracking Information | |||||
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First Submitted Date ICMJE | January 17, 2019 | ||||
First Posted Date ICMJE | January 22, 2019 | ||||
Last Update Posted Date | January 23, 2019 | ||||
Actual Study Start Date ICMJE | November 21, 2018 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective Response Rates (ORR) [ Time Frame: up to two year ] the ratio of patients who are evaluated as CR or PR
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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 |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Toripalimab as Monotherapy for Patients With Small Cell Carcinoma of Esophagus Who Failed Chemotherapy | ||||
Official Title ICMJE | Phase II Clinical Trial of Toripalimab (JS001), a Recombinant Humanized Anti-PD-1 Monoclonal PD1 Antibody, as Monotherapy for Patients With Small Cell Esophageal Carcinoma Who Failed Chemotherapy | ||||
Brief Summary | To evaluate the anti-tumor activity, safety and tolerance of toripalimab as monotherapy for patients with small cell esophageal cancer (SCCE), and to explore the potential biomarkers for this treatment. | ||||
Detailed Description | For the first time in the world, the investigators revealed the genomic characteristics of SCCE and constructed a complete genomic profile of SCCE. The analysis of transcriptome data showed that the number of effector T cells in SCCE immune microenvironment was significantly higher than that of other cancers, and NK cells were relatively high. Macrophages in SCCE mainly showed M2-like phenotype and maintained at a relatively high level, suggesting the possibility of immunotherapy in SCCE treatment. Therefore, the purpose of this study is to clarify the efficacy of PD-1 antibody in the treatment of patients with SCCE who failed chemotherapy, so as to provide a basis for further large-scale clinical research. | ||||
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 |
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Intervention ICMJE | Drug: Toripalimab
Drug: Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
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Study Arms ICMJE | Experimental: Toripalimab
Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
Intervention: Drug: Toripalimab
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Publications * | Not Provided | ||||
* 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 30, 2021 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
(1) heart failure above NYHA Level 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 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 | NCT03811379 | ||||
Other Study ID Numbers ICMJE | PD-1/SCCE | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ruihua Xu, 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 | January 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |