Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study
Study Details
Study Description
Brief Summary
This is a multi-center, retrospective, real-world study. The purpose of this study is to observe the effectiveness and safety of regorafenib in Chinese advanced colorectal cancer patients.
The main observational goals include overall survival(OS), 6 month OS rate, 1 year OS rate, and treatment time failure (TTF), other study goals include objective response rate( ORR)、Disease control rate（DCR）and adverse event(AE) of regorafenib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 6-month Overall Survival rate [6 month]
6 months OS rate of patients who received regorafenib treatment.
- 1 year Overall Survival rate [1 year]
1 year OS rate of patients who received regorafenib treatment.
- overall survival [1 year]
overall survival of patients who received regorafenib treatment.
Secondary Outcome Measures
- objective response rate [1 year]
Investigator assessed according to RECIST v1.1
- Disease control rate [1 year]
Investigator assessed according to RECIST v1.1
- Incidence of Adverse Events (AEs) [1 year]
Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with colorectal cancer confirmed by pathological tissue or cytology；
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The pathological type of colorectal tumor was adenocarcinoma；
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Patients with recurrent or metastatic, unresectable advanced colorectal cancer；
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Patients who received regorafenib at least one period treatment.
Exclusion Criteria:
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Patients participating in other interventional clinical studies while taking regorafenib;
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Patients with other malignant tumors within 5 years before regorafenib treatment, except for cured cervical carcinoma in situ, skin squamous cell carcinoma or basal cell carcinoma, early papillary thyroid carcinoma, etc.;
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The investigator deems that there are other factors that are not suitable for patients who participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital,Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100021 |
| 2 | National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College | Beijing | China | 100021 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
- Beijing Hospital
- Jiangsu Cancer Institute & Hospital
- The Affiliated Hospital of Qingdao University
- Shanxi Province Cancer Hospital
- Affiliated Hospital of Hebei University
- Shandong Cancer Hospital and Institute
- The First Affiliated Hospital of Zhengzhou University
- Hebei Medical University Fourth Hospital
- First Hospital of China Medical University
Investigators
- Study Chair: Yunbo Zhao, Beijing Hospital
- Study Chair: Liangjun Zhu, Jiangsu Cancer Institute & Hospital
- Study Chair: Zimin Liu, The Affiliated Hospital of Qingdao University
- Study Chair: Wei Bai, Shanxi Provincial Cancer Hospital
- Study Chair: Aimin Zang, Affiliated Hospital of Hebei University
- Study Chair: Bo Liu, Shandong Cancer Hospital and Institute
- Study Chair: Hong Zong, The First Affiliated Hospital of Zhengzhou University
- Study Chair: Shengmian Li, The fourth hospital of Hebei medical university and hebei cancer hospital
- Study Chair: Xiujuan Qu, First Hospital of China Medical University
- Principal Investigator: Aiping Zhou, Cancer hospital Chinese academy of medical science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChineseAcademyMedicalSciences