| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Squamous Cell Carcinoma by AJCC V8 Stage Resectable Esophageal Cancer | Drug: Toripalimab Drug: Paclitaxel/cisplatin Radiation: Intensity-modulated radiotherapy Procedure: Esophagectomy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 44 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma |
| Actual Study Start Date : | June 25, 2019 |
| Estimated Primary Completion Date : | June 30, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Toripalimab group
All patients will receive standard fractionation radiation therapy (RT) scheme: 44Gy in 20 fractions over 4 weeks, concurrently with 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 and 2 cycles of toripalimab 240 mg on days 1, 22. Esophagectomy is performed 6-8 weeks after CRT completion.
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Drug: Toripalimab
Patients received toripalimab 240 mg IVDRIP on days 1 and 22 during neoadjuvant radiotherapy.
Other Name: JS-001
Drug: Paclitaxel/cisplatin Patients received 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 during neoadjuvant radiotherapy.
Other Name: TP
Radiation: Intensity-modulated radiotherapy All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 44 Gy in 20 fractions over 4 weeks.
Other Name: IMRT
Procedure: Esophagectomy A transthoracic (Ivor-Lewis) esophagectomy is performed 6-8 weeks after CRT completion.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Mian Xi, MD | 86-20-87343385 | ximian@sysucc.org.cn | |
| Contact: Hong Yang, MD | 86-20-87343093 | yanghong@sysucc.org.cn |
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Mian Xi, MD 86-20-87343385 ximian@sysucc.org.cn | |
| Principal Investigator: Jianhua Fu, MD | |
| Principal Investigator: | Jianhua Fu, MD | Sun Yat-sen University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||||||
| First Posted Date ICMJE | July 2, 2019 | ||||||||
| Last Update Posted Date | December 26, 2019 | ||||||||
| Actual Study Start Date ICMJE | June 25, 2019 | ||||||||
| Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pathologic complete response rate [ Time Frame: Three working days after surgery ] The rate of pathologic complete response rate after neoadjuvant chemoradiotherapy.
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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 | Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Cancer | ||||||||
| Official Title ICMJE | A Phase II Trial of Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Squamous Cell Carcinoma | ||||||||
| Brief Summary | Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal cancer (EC). However, only 20% to 40% of EC patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody) combined with neoadjuvant CRT in locally advanced esophageal squamous cell carcinoma (ESCC). | ||||||||
| 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 |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Toripalimab group
All patients will receive standard fractionation radiation therapy (RT) scheme: 44Gy in 20 fractions over 4 weeks, concurrently with 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 and 2 cycles of toripalimab 240 mg on days 1, 22. Esophagectomy is performed 6-8 weeks after CRT completion.
Interventions:
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| Publications * |
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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 |
44 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2020 | ||||||||
| Estimated Primary Completion Date | June 30, 2020 (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 70 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 | NCT04006041 | ||||||||
| Other Study ID Numbers ICMJE | TORINEOEC | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jianhua Fu, Sun Yat-sen University | ||||||||
| Study Sponsor ICMJE | Jianhua Fu | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Sun Yat-sen University | ||||||||
| Verification Date | December 2019 | ||||||||
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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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