A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04187352 |
Recruitment Status :
Completed
First Posted : December 5, 2019
Last Update Posted : November 24, 2023
|
Sponsor:
CStone Pharmaceuticals
Information provided by (Responsible Party):
CStone Pharmaceuticals
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | December 3, 2019 | ||||
First Posted Date ICMJE | December 5, 2019 | ||||
Last Update Posted Date | November 24, 2023 | ||||
Actual Study Start Date ICMJE | December 19, 2019 | ||||
Actual Primary Completion Date | October 7, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE |
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma | ||||
Official Title ICMJE | A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) | ||||
Brief Summary | Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE | Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
540 | ||||
Original Estimated Enrollment ICMJE |
420 | ||||
Actual Study Completion Date ICMJE | October 7, 2022 | ||||
Actual Primary Completion Date | October 7, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04187352 | ||||
Other Study ID Numbers ICMJE | CS1001-304 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | CStone Pharmaceuticals | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | CStone Pharmaceuticals | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | CStone Pharmaceuticals | ||||
Verification Date | November 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |