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

Recruiting
18 - 85 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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 details

Colorectal Cancer

NCT05818267

Wei Zhang

26 January 2024

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