Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer | Drug: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma |
Actual Study Start Date : | January 21, 2020 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | June 1, 2022 |
Arm | Intervention/treatment |
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Experimental: SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine
trastuzumab + SHR-1210 + capecitabine + oxaliplatin for neoadjuvant chemotherapy 4-cycle.Then D2 radical surgery. The patients continued to receive capecitabine plus oxaliplatin for adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.
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Drug: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine
|
Defined as the proportion of patients with a documented complete response, and partial response (CR
+ PR )
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (cT4 or / and N+M0, MDT believes that perioperative treatment is required):
Exclusion Criteria:
25. Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test. Accept other experimental drugs within 28 days before the start of the test 26. Women who are pregnant or lactating, or women who are planning to become pregnant within 5 months of the end of treatment. Women of childbearing age are required to undergo a blood pregnancy test within 7 days prior to the start of the trial.
Contact: Ning Li | 13526501903 | lining97@126.com |
China, Henan | |
Henan Cancer Hospital | Recruiting |
Zhengzhou, Henan, China, 450008 | |
Contact: Ning Li, PhD 0086-13526501903 lining97@126.com | |
Principal Investigator: Ning Li, PhD | |
Principal Investigator: Suxia Luo, PhD |
Principal Investigator: | Suxia Luo | Henan Cancer Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | May 13, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | May 29, 2020 | ||||
Actual Study Start Date ICMJE | January 21, 2020 | ||||
Estimated Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Disease Free Survival(DFS) [ Time Frame: up to 2 year ] The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason
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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 | SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma | ||||
Official Title ICMJE | Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma | ||||
Brief Summary | The aim of this study is to observe the efficacy and safety of immume checkpoint inhibitor PD-1 SHR1210 combined with Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. | ||||
Detailed Description | This study is a prospective, one-arm, phase II clinical study to evaluate the safety and efficacy of SHR-1210 in combination with trastuzumab plus oxaliplatin and capecitabine for HER2-positive locally advanced resectable gastric adenocarcinoma and gastroesophageal junction adenocarcinoma during the perioperative treatment. | ||||
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: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine
|
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Study Arms ICMJE | Experimental: SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine
trastuzumab + SHR-1210 + capecitabine + oxaliplatin for neoadjuvant chemotherapy 4-cycle.Then D2 radical surgery. The patients continued to receive capecitabine plus oxaliplatin for adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.
Intervention: Drug: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine
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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 |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2022 | ||||
Estimated Primary Completion Date | December 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
25. Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test. Accept other experimental drugs within 28 days before the start of the test 26. Women who are pregnant or lactating, or women who are planning to become pregnant within 5 months of the end of treatment. Women of childbearing age are required to undergo a blood pregnancy test within 7 days prior to the start of the trial. |
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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 | NCT03950271 | ||||
Other Study ID Numbers ICMJE | GCCG7 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Henan Cancer Hospital | ||||
Study Sponsor ICMJE | Henan Cancer Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Henan Cancer Hospital | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |