Condition or disease | Intervention/treatment | Phase |
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Locally Advanced Esophageal Squamous Cell Carcinoma | Drug: SHR-1210+docetaxel+nedaplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma |
Actual Study Start Date : | April 7, 2020 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2022 |
Arm | Intervention/treatment |
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Experimental: SHR-1210+Docetaxel+nedaplatin
SHR-1210+Docetaxel+nedaplatin
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Drug: SHR-1210+docetaxel+nedaplatin
neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
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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:
(1)Blood routine examination:
a.HB≥90g/L;b.ANC ≥ 1.5 × 109 / L;c.PLT ≥ 80 × 109 / L; (2)Biochemical examination:
a.ALB ≥ 30g / L;b.ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN;c.TBIL ≤ 1.5ULN;d.plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 7.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 8.Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9.Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion Criteria:
Contact: Feng Wang | 13938244776 | fengw010@163.com |
China, Henan | |
The First Affiliated Hospital of Zhengzhou University | Recruiting |
Zhengzhou, Henan, China, 450052 | |
Contact: Feng Wang, doctor |
Principal Investigator: | Feng Wang | The First Affiliated Hospital of Zhengzhou University |
Tracking Information | |||||
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First Submitted Date ICMJE | April 14, 2019 | ||||
First Posted Date ICMJE | April 17, 2019 | ||||
Last Update Posted Date | October 1, 2020 | ||||
Actual Study Start Date ICMJE | April 7, 2020 | ||||
Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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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 | The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma | ||||
Official Title ICMJE | The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma | ||||
Brief Summary | The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma | ||||
Detailed Description | In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. Investigator designed a single-arm, open-label, phase II trial of SHR-1210 combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma. | ||||
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 | Locally Advanced Esophageal Squamous Cell Carcinoma | ||||
Intervention ICMJE | Drug: SHR-1210+docetaxel+nedaplatin
neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
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Study Arms ICMJE | Experimental: SHR-1210+Docetaxel+nedaplatin
SHR-1210+Docetaxel+nedaplatin
Intervention: Drug: SHR-1210+docetaxel+nedaplatin
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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 |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2022 | ||||
Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
(1)Blood routine examination: a.HB≥90g/L;b.ANC ≥ 1.5 × 109 / L;c.PLT ≥ 80 × 109 / L; (2)Biochemical examination: a.ALB ≥ 30g / L;b.ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN;c.TBIL ≤ 1.5ULN;d.plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 7.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 8.Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9.Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up. 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 | NCT03917966 | ||||
Other Study ID Numbers ICMJE | SHR-1210-02 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Feng Wang, The First Affiliated Hospital of Zhengzhou University | ||||
Study Sponsor ICMJE | The First Affiliated Hospital of Zhengzhou University | ||||
Collaborators ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Investigators ICMJE |
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PRS Account | The First Affiliated Hospital of Zhengzhou University | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |