Advanced Colorectal Cancer
Conditions
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.
Interventions
None listed
Sponsors
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
Chinese Academy of Medical Sciences
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with colorectal cancer confirmed by pathological tissue or cytology； 2. The pathological type of colorectal tumor was adenocarcinoma； 3. Patients with recurrent or metastatic, unresectable advanced colorectal cancer； 4. Patients who received regorafenib at least one period treatment.
Exclusion criteria
1. Patients participating in other interventional clinical studies while taking regorafenib; 2. 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.; 3. The investigator deems that there are other factors that are not suitable for patients who participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed