Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer | Drug: Propranolol | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 78 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Propranolol Combined With Neoadjuvant Chemotherapy in Stage III-IV Gastric Cancer: an Open-lable, Single-arm Study |
Actual Study Start Date : | November 20, 2019 |
Estimated Primary Completion Date : | June 1, 2020 |
Estimated Study Completion Date : | June 1, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Prop+neochemo |
Drug: Propranolol
add propranolol in gastric cancer patients who need to receive preoperate 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:
Exclusion Criteria:
China, Hunan | |
Xiangya Hospital Central South University | Recruiting |
Changsha, Hunan, China, 410008 | |
Contact: Yijing He, MD, PhD +86-15874812612 yijinghe@gmail.com |
Tracking Information | |||||||
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First Submitted Date ICMJE | June 29, 2019 | ||||||
First Posted Date ICMJE | July 2, 2019 | ||||||
Last Update Posted Date | November 26, 2019 | ||||||
Actual Study Start Date ICMJE | November 20, 2019 | ||||||
Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
ORR [ Time Frame: Preoperative assessment ] CR+PR
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
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 | Clinical Study of Propranolol Combined With Neoadjuvant Chemotherapy in Gastric Cancer | ||||||
Official Title ICMJE | Efficacy and Safety of Propranolol Combined With Neoadjuvant Chemotherapy in Stage III-IV Gastric Cancer: an Open-lable, Single-arm Study | ||||||
Brief Summary | At the cellular and animal level, we found that propranolol can inhibit the proliferation and invasion of gastric cancer cells. Further, we want to explore the efficacy and safety of propranolol in the treatment of gastric cancer patients. | ||||||
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 | Gastric Cancer | ||||||
Intervention ICMJE | Drug: Propranolol
add propranolol in gastric cancer patients who need to receive preoperate chemotherapy
|
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Study Arms ICMJE | Experimental: Prop+neochemo
Intervention: Drug: Propranolol
|
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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 |
78 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 1, 2020 | ||||||
Estimated Primary Completion Date | June 1, 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 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04005365 | ||||||
Other Study ID Numbers ICMJE | 2019/prop/GC/CSU | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Yijing He, Central South University | ||||||
Study Sponsor ICMJE | Yijing He | ||||||
Collaborators ICMJE | Xiangya Hospital of Central South University | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Central South University | ||||||
Verification Date | November 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |