Condition or disease | Intervention/treatment | Phase |
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Metastatic Gastric Adenocarcinoma | Drug: S1 Drug: Paclitaxel Drug: Bevacizumab Drug: Oxaliplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | S1 Plus Paclitaxel (IV&IP) Plus Bevacizumab (IP) Versus S1 Plus Oxaliplatin(IV) as First-line Treatment in Gastric or Gastroesophageal Junctional Adenocarcinoma With Malignant Ascites: An Open-label, Multicenter Phase II Study |
Actual Study Start Date : | November 1, 2017 |
Estimated Primary Completion Date : | April 30, 2021 |
Estimated Study Completion Date : | April 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Experimental arm
S1+Paclitaxel (IV&IP)+Bevacizumab (IP)
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Drug: S1
80-120 mg/day, PO, D1-14, every 21 days
Other Name: Tegafur Gimeracil Oteracil Potassium Capsule
Drug: Paclitaxel 20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days
Other Name: Paclitaxel Injection
Drug: Bevacizumab 200 mg, IP, D1, every 21 days
Other Name: Avastin ®
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Active Comparator: Control arm
S1+Oxaliplatin (IV)
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Drug: S1
80-120 mg/day, PO, D1-14, every 21 days
Other Name: Tegafur Gimeracil Oteracil Potassium Capsule
Drug: Oxaliplatin 130 mg/m2, IV, D1, every 21 days
Other Name: ELOXATIN®
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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: Yunpeng Liu, M.D. | 86-24-83282312 | cmu_trial@163.com | |
Contact: Xiujuan Qu, M.D. | 86-24-83282312 | cmuquxiujuan@163.com |
China, Liaoning | |
The First Affiliated Hospital of China Medical University | Recruiting |
Shenyang, Liaoning, China, 110001 | |
Contact: Yunpeng Liu, Ph.D | |
Contact: Xiujuan Qu, M.D. |
Principal Investigator: | Yunpeng Liu, M.D. | China Medical University, China |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 28, 2019 | ||||||||
First Posted Date ICMJE | June 18, 2019 | ||||||||
Last Update Posted Date | June 19, 2019 | ||||||||
Actual Study Start Date ICMJE | November 1, 2017 | ||||||||
Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Ascites response rate at 6 weeks [ Time Frame: 6 weeks ] response of ascites at 6 weeks
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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 | S1+ Paclitaxel (IV&IP) + Bevacizumab (IP) Versus S1+Oxaliplatin as First-line Treatment in Gastric Cancer With Malignant Ascites | ||||||||
Official Title ICMJE | S1 Plus Paclitaxel (IV&IP) Plus Bevacizumab (IP) Versus S1 Plus Oxaliplatin(IV) as First-line Treatment in Gastric or Gastroesophageal Junctional Adenocarcinoma With Malignant Ascites: An Open-label, Multicenter Phase II Study | ||||||||
Brief Summary | The purpose of this study is to compare the efficacy of S1 plus paclitaxel (intravenous injection & intraperitoneal injection) plus bevacizumab (intraperitoneal injection) vs. S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites. | ||||||||
Detailed Description | This is a prospective, open-label, multicenter clinical trial, to compare the efficacy of S1 plus paclitaxel (intravenous injection & intraperitoneal injection) plus bevacizumab (intraperitoneal injection) versus S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites. A total of 66 patients who are diagnosed with gastric or gastroesophageal junctional adenocarcinoma will be allocated to receive either S1 orally administration plus paclitaxel intravenous injection & intraperitoneal injection plus bevacizumab intraperitoneal injection, or to receive S1 orally administration plus oxaliplatin intravenous injection. The primary end point is ascites response rate at 6 weeks. The secondary end points include the median overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), objective response rate (ORR), puncture free survival, volume of drainage, the quality of life (QoL) and safety. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Gastric Adenocarcinoma | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 |
66 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 30, 2022 | ||||||||
Estimated Primary Completion Date | April 30, 2021 (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 | NCT03990103 | ||||||||
Other Study ID Numbers ICMJE | CLOG1704 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Yunpeng Liu, China Medical University, China | ||||||||
Study Sponsor ICMJE | China Medical University, China | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | China Medical University, China | ||||||||
Verification Date | June 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |