Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer

• Conditions: Advanced Colorectal Carcinoma

• Registration Number: NCT04771715
• Lead Sponsor: Peking Union Medical College Hospital

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 routine clinical practice. The primary end point is overall survival. The secondary endpoints include progression-free survival, objective response rate, disease control rate and the incidence of treatment-related adverse events.

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 medical centers. Patients received the study treatment as part of routine medical care based on the consensus of clinicians and patients. In addition to the primary and secondary outcomes, other patient and treatment characteristics including baseline microsatellite instability status, metastatic sites, previous treatment regimens, post-treatment regimens, are collected in order to describe the real-world treatment patterns.

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 18 years of age and older
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

1. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
2. Participation in other interventional studies while receiving regorafenib plus a PD-1 inhibitor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 24 months	The time from treatment initiation to death due to any cause

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 24 months	The time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first
Objective response rate (ORR)	Up to 12 months	The proportion of participants in the analysis population who have complete response (CR) or partial response (PR) determined by investigators using RECIST 1.1 criteria at any time during the study
Disease control rate (DCR)	Up to 12 months	The proportion of participants in the analysis population who have CR, PR or stable disease (SD) determined by investigators using RECIST 1.1 criteria at any time during the study
Incidence of treatment-related adverse events (TRAE)	Up to 24 months	Percentage of participants with TRAEs as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China