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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Real-world Study of Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Chinese Patients With Advanced Colorectal Cancer

Conditions
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Advanced Colorectal Carcinoma

Intervention / Treatment
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* Drug: Regorafenib
* Drug: Nivolumab
* Drug: Pembrolizumab
* Drug: Camrelizumab
* Drug: Sintilimab
* Drug: Toripalimab
* Drug: Tislelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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.|
|Drug: 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.|
|Drug: 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.|
|Drug: 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.|
|Drug: 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.|
|Drug: 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.|
|Drug: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The time from treatment initiation to death due to any cause | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first | Up to 24 months | 
| Objective response rate (ORR) | 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 | Up to 12 months | 
| Disease control rate (DCR) | 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 | Up to 12 months | 
| Incidence of treatment-related adverse events (TRAE) | Percentage of participants with TRAEs as assessed by CTCAE v4.0 | Up to 24 months |