Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer
NCT ID: NCT04771715
Last Updated: 2021-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-05-01
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Regorafenib
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Nivolumab
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Pembrolizumab
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Camrelizumab
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Sintilimab
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Toripalimab
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Tislelizumab
Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma
3. Disease progression on standard of care therapy
4. Patients must have received at least one dose of PD-1 inhibitors in combination with regorafenib
5. At least one available laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment for safety analysis
6. Confirmed treatment discontinuation/disease progression/available radiological evaluation or at least eight weeks of follow-up subsequent to the first dose of study treatment for efficacy analysis
7. Prior exposure to regorafenib monotherapy or a PD-1 inhibitor monotherapy was allowed
Exclusion Criteria
2. Participation in other interventional studies while receiving regorafenib plus a PD-1 inhibitor
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Countries
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References
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Yang K, Han L, Wu S, Qu X, Li Q, Zhao C, Zhou J, Jin X, Wang Y, Yan D, Cheng Z, Hua Y, Zhang Y, Ge Y, Sun J, Deng W, Zhao L, Zhao Y. Real-world outcomes of regorafenib combined with immune checkpoint inhibitors in patients with advanced or metastatic microsatellite stable colorectal cancer: A multicenter study. Cancer Immunol Immunother. 2022 Jun;71(6):1443-1451. doi: 10.1007/s00262-021-03083-3. Epub 2021 Oct 24.
Other Identifiers
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S-K1517
Identifier Type: -
Identifier Source: org_study_id
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