Condition or disease | Intervention/treatment | Phase |
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Esophageal Squamous Cell Carcinoma | Drug: Sintilimab + chemotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Exploratory Study of the Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Single-center, Single-arm Study |
Actual Study Start Date : | December 1, 2020 |
Estimated Primary Completion Date : | June 1, 2022 |
Estimated Study Completion Date : | July 1, 2022 |
Arm | Intervention/treatment |
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Experimental: Arm 1
Pre-operative Sintilimab + chemotherapy
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Drug: Sintilimab + chemotherapy
Biological : Sintilimab 100mg: 10ml Method of administration: 200mg IV D1 Q3W. Drug: Cisplatin Injection Specification: 75mg/m2, IV D1 Q3W. Drug: Albumin Paclitaxel Injection specifications: 260mg/m2, IV D1 Q3W.
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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:
Contact: Jun Zhao | 86-0512-67972216 | zhaojia0327@126.com |
China, Jiangsu | |
The first affiliated hospital of soochow university | Recruiting |
Suzhou, Jiangsu, China, 215000 | |
Contact: Jun Zhao 86-0512-67972216 zhaojia0327@126.com |
Tracking Information | |||||
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First Submitted Date ICMJE | December 13, 2021 | ||||
First Posted Date ICMJE | December 30, 2021 | ||||
Last Update Posted Date | December 30, 2021 | ||||
Actual Study Start Date ICMJE | December 1, 2020 | ||||
Estimated Primary Completion Date | June 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pathologic complete remission (PCR) [ Time Frame: 4 weeks after surgery ] Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
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 | Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell Carcinoma | ||||
Official Title ICMJE | Phase II Exploratory Study of the Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Single-center, Single-arm Study | ||||
Brief Summary | This study aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. It will also evaluate the changes in the immune microenvironment of tumor specimens before and after the medication, and predict the operable period (stage I~III) Patients with thoracic esophageal squamous cell carcinoma were treated with neoadjuvant chemotherapy combined with PD-1 monoclonal antibody, and the effect of neoadjuvant chemotherapy combined with PD-1 monoclonal antibody was evaluated by detecting the changes of microbial diversity and metabolites in stool samples before and after treatment. | ||||
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 | Esophageal Squamous Cell Carcinoma | ||||
Intervention ICMJE | Drug: Sintilimab + chemotherapy
Biological : Sintilimab 100mg: 10ml Method of administration: 200mg IV D1 Q3W. Drug: Cisplatin Injection Specification: 75mg/m2, IV D1 Q3W. Drug: Albumin Paclitaxel Injection specifications: 260mg/m2, IV D1 Q3W.
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Study Arms ICMJE | Experimental: Arm 1
Pre-operative Sintilimab + chemotherapy
Intervention: Drug: Sintilimab + chemotherapy
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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 |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 1, 2022 | ||||
Estimated Primary Completion Date | June 1, 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 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 | NCT05174325 | ||||
Other Study ID Numbers ICMJE | 20211210 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | The First Affiliated Hospital of Soochow University | ||||
Study Sponsor ICMJE | The First Affiliated Hospital of Soochow University | ||||
Collaborators ICMJE | Innovent Biologics (Suzhou) Co. Ltd. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | The First Affiliated Hospital of Soochow University | ||||
Verification Date | December 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |