Status:
UNKNOWN
Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Advanced Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter observational study aimed to describe the efficacy and safety of regorafenib plus programmed cell death-1 (PD-1) inhibitors in Chinese patients with advanced colorectal cancer in...
Detailed Description
The investigators retrospectively identify patients with advanced colorectal adenocarcinoma who received at least one dose of PD-1 inhibitors plus regorafenib from 5/2019 to 2/2021 in 14 Chinese medic...
Eligibility Criteria
Inclusion
- 18 years of age and older
- Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma
- Disease progression on standard of care therapy
- Patients must have received at least one dose of PD-1 inhibitors in combination with regorafenib
- At least one available laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment for safety analysis
- 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
- Prior exposure to regorafenib monotherapy or a PD-1 inhibitor monotherapy was allowed
Exclusion
- Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
- Participation in other interventional studies while receiving regorafenib plus a PD-1 inhibitor
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04771715
Start Date
May 1 2019
End Date
March 31 2021
Last Update
February 25 2021
Active Locations (1)
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1
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100032