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

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Colorectal Carcinoma
• Intervention / Treatment: Drug: Regorafenib; Drug: Nivolumab; Drug: Pembrolizumab; Drug: Camrelizumab; Drug: Sintilimab; Drug: Toripalimab; Drug: Tislelizumab

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100032
    • Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators performed a retrospective review of medical records to identify patients with advanced colorectal cancer who received at least one dose of PD-1 inhibitors in combination with regorafenib as routine medical care in 14 Chinese medical centers.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Yang K, Han L, Wu S, Qu X, Li Q, Zhao C, Zhou J, Jin X, Wang Y, Yan D, Cheng Z, Hua Y, Zhang Y, Ge Y, Sun J, Deng W, Zhao L, Zhao Y. Real-world outcomes of regorafenib combined with immune checkpoint inhibitors in patients with advanced or metastatic microsatellite stable colorectal cancer: A multicenter study. Cancer Immunol Immunother. 2022 Jun;71(6):1443-1451. doi: 10.1007/s00262-021-03083-3. Epub 2021 Oct 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): February 28, 2021
• Study Completion (ANTICIPATED): March 31, 2021

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab
• Other Study ID Numbers: S-K1517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO