Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)

Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC) Without Imaging Progress Three Months After Second-Line Treatment

Regorafenib in third-line treatment of metastatic colorectal cancer(mCRC) significantly prolongs the survival of patients, and its advancement has a sensitizing effect on postline chemotherapy and thus improves the prognosis of patients. Therefore, the present study was designed to include patients who achieved stable disease/partial response(SD/PR) after 3 months of second-line therapy and advance regorafenib to investigate the role of advance regorafenib in prolonging progression-free survival, prolonging the efficacy of overall survival, safety, and quality of life in patients with mCRC compared with standard second-line and third-line therapy.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Regorafenib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Department of Colorectal Surgery in Changhai Hospital
      • Contact: Wei Zhang; Phone Number: 021-31161613; Email: weizhang2000cn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with histologically or cytologically confirmed metastatic colorectal cancer who have measurable metastatic disease according to the Resolute Efficacy Criteria for Solid Tumors (RECIST) version 1.1.
• Received standard second-line therapy, achieved stable disease(SD) and above by recist1.1 tumor assessment and maintained for 3 months.
• Eastern Oncology Collaborative Group(ECOG) physical status of 0 or 1 at trial entry and life expectancy ≥ 3 months.
• No bone marrow suppression and normal heart, lung, liver and kidney function.
• Voluntary participation in research.

Exclusion Criteria:

• Concurrent primary tumors of other types.
• MSI-H/dMMR type mCRC patients.
• Heart, liver, kidney, bone marrow insufficiency or mental abnormalities.
• Intolerant to treatment methods
• Concurrent participants in other clinical trials.
• Pregnant or lactating women.
• Patients deemed unsuitable for study participation by the remaining investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment group; The drug dose that taken by the subject is gradually increased to the maximum dose tolerated by the patient according to individualization. Specifically, the initial dose of 80 mg/day was gradually increased to 120 mg/day (80 mg/day in the first week, 120 mg/day in the second week, and a maximum tolerated dose of 160 mg/day). The maximum tolerated dose is 160 mg/day. The dose is administered once daily in a 4-week cycle (3 weeks of dosing and 1 week of rest) and the maximum dose achieved in the first treatment cycle is maintained.At the discretion of the investigator, regorafenib may be delayed or discontinued. Dose adjustments and interruptions due to toxicity are made according to the recommendations specified in the protocol.

Drug: Regorafenib; The drug dose that taken by the subject is gradually increased to the maximum dose tolerated by the patient according to individualization. Specifically, the initial dose of 80 mg/day was gradually increased to 120 mg/day (80 mg/day in the first week, 120 mg/day in the second week, and a maximum tolerated dose of 160 mg/day). The maximum tolerated dose is 160 mg/day. The dose is administered once daily in a 4-week cycle (3 weeks of dosing and 1 week of rest) and the maximum dose achieved in the first treatment cycle is maintained.At the discretion of the investigator, regorafenib may be delayed or discontinued. Dose adjustments and interruptions due to toxicity are made according to the recommendations specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of disease control(DDC)	From second-line treatment initiation to third disease progression	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival(OS)	Subjects were censored from the time of enrollment to the time of death from any cause, and the date of censoring was the date of the last follow-up visit if the subject's last status was alive.	3 years
Quality-of-Life(QoL)	Quality-of-life was evaluated using the Quality-of-Life Questionnaire C30 (EORTC QLQ-C 30) developed by the European organization for research and treatment of cancer (EORTC)	3 years
The incidence of adverse events	Adverse Events (AE) will be evaluated and graded according to NCI-CTCAE v5.0. All adverse events will be reported at length.	3 years

Collaborators and Investigators

• Sponsor: Wei Zhang

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

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
• Other Study ID Numbers: RE-SUSTAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No