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

NCT04771715 | Unknown

• 1 other identifier: S-K1517
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The time from treatment initiation to death due to any cause

  Up to 24 months

Secondary Outcomes (4)

• Progression-free survival

  Up to 24 months

• Objective response rate (ORR)

  Up to 12 months

• Disease control rate (DCR)

  Up to 12 months

• Incidence of treatment-related adverse events (TRAE)

  Up to 24 months

Interventions

Regorafenib DRUG

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.

Also known as: Stivarga

Nivolumab DRUG

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.

Also known as: Opdivo

Pembrolizumab DRUG

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.

Also known as: Keytruda

Camrelizumab DRUG

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 DRUG

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 DRUG

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 DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100032, China

Location

Related Publications (1)

• 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.

  PMID: 34689233 DERIVED

MeSH Terms

Interventions

regorafenib; Nivolumab; pembrolizumab; camrelizumab; sintilimab; toripalimab; tislelizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 25, 2021
• Study Start: May 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: March 31, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)