Efficacy and Safety of Sintilimab Combined With Regorafenib and Cetuximab / Sintilimab Combined With Regorafenib in Posterior Line Therapy of Advanced Colorectal Cancer (Regosinti)

• Status: Not yet recruiting
• Trial end date: 2022-12-31

Summary

The incidence of colorectal cancer ranks the third in the world and the mortality ranks the second in the world. The incidence and mortality of colorectal cancer have increased in China in the past decade. The incidence of colorectal cancer is associated with dietary patterns, obesity and lifestyle. The 2010 colorectal cancer survey in China showed that the incidence of colorectal cancer was low in the age group below 50 years old, and began to increase rapidly in the age group above 50 years old, reached the maximum in the age group above 70 years old, and decreased after 80 years old.

For advanced colorectal cancer, systemic chemotherapy, local radiotherapy, synchronous or sequential chemoradiotherapy are lack of specificity, killing tumor cells as well as human normal cells, and the space for the traditional cytotoxic chemotherapy drugs to further improve the clinical efficacy of anti-malignant tumor is very limited. Therefore, molecular targeted tumor therapy with strong specificity and relatively small toxic and side effects has gradually become the fourth treatment mode following the three conventional treatment methods of surgery, radiotherapy and chemotherapy. Epidermal growth factor receptor (EGFR) is a clear target for treatment of advanced colorectal cancer. Immunotherapy has been a hot topic in recent years, In the field of colorectal cancer, studies on MSI-H population have been carried out successively since ASCO in 2015.However, the MSI-H population accounts for only 5% of patients with advanced colorectal cancer and 12-15% of total colorectal cancer, and the benefit population is very limited.

Cetuximab is approved for the treatment of advanced colorectal cancer in the United States, Europe and China. Cetuximab in combination with chemotherapy is the standard treatment for RAS wild-type (RAS-WT) colorectal cancer. PD-1 monotherapy has been approved for patients with MSI-H/ DMMR colorectal cancer. The approved PD-1 mAb includes Nivolumab and Pembrolizumab. In some small trials, PD-1 monoclonal antibody combined with Regorafenib showed initial efficacy in patients with MSS type advanced colorectal cancer. EGFR signaling pathway blocker combined with PD-1 antibody, a new treatment mode, is of great significance to enrich the content of immunotherapy for patients with colorectal cancer, improve the survival prognosis of patients, and search for new efficacy predictors.

In conclusion, this study, on the one hand, is expected to confirm that RAS and RAF wild-type advanced colorectal cancer and MSS type can benefit from Sintilimab combined with Regorafenib treatment, and at the same time, observe the effective rate of this regimen in the mutant group, so as to provide reference for clinical selection.

• Phase: Phase 2

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Cetuximab