Fruquintinib/Regorafenib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Metastatic Colorectal Cancer (FREST-CRC)

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for advanced metastatic colorectal cancer (CRC), which is cancer that has spread beyond the colon and rectum. The study is testing a combination of three treatments: Sintilimab (an immunotherapy), Fruquintinib or Regorafenib (targeted therapies), and radiotherapy. The goal is to see how well this combination works in helping patients live longer and improve their overall health, especially for those with or without liver metastases. The trial will focus on how long patients can live without their cancer getting worse and how well they respond to the treatment.

To participate in the trial, patients must be adults aged 18 or older with confirmed metastatic colorectal cancer who have already received standard treatments. They need to have at least one measurable tumor that can be tracked during the study. Participants should also be in good overall health and not have other significant medical conditions that could complicate treatment. Throughout the trial, patients will receive regular check-ups, and their health will be closely monitored to ensure safety and gather important information about the effectiveness of the treatment. This trial aims to provide new insights that could lead to better, personalized treatments for people facing advanced colorectal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ECOG PS 0-2
• • Histologically confirmed metastatic colorectal adenocarcinoma (8th edition AJCC)
• • RAS and BRAF gene mutations or wild type, MSS subtype
• • Previously received standard first- and second-line systemic anti-tumor therapy
• • At least one measurable lesion as defined by RECIST 1.1 criteria
• • Access to tumor samples for biomarker assessment
• • Expected survival of ≥3 months
• • Normal function of major organ systems (within 14 days before enrollment)
• • No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.
• • Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.
• Exclusion Criteria:
• • Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.
• • Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.
• • Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, and regorafenib.
• • Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).
• • Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.
• • Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.
• • Received liver radiotherapy within the past 2 weeks before enrollment.
• • Known presence of central nervous system metastases and/or carcinomatous meningitis.
• • Received systemic corticosteroid therapy within 7 days before enrollment.