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

Advanced Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04771715
• Other study ID #: S-K1517
• Status: Active, not recruiting
• Start date: May 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The time from treatment initiation to death due to any cause	Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of treatment-related adverse events (TRAE)	Percentage of participants with TRAEs as assessed by CTCAE v4.0	Up to 24 months