Clinical Trial Registered to Study Neoadjuvant Treatment for Locally Advanced Rectal Cancer

Medical researchers in China are exploring a new treatment approach for locally advanced rectal cancer by combining neoadjuvant therapy with citrus flavonoid tablets. The clinical trial, registered with the Chinese Clinical Trial Registry, aims to evaluate the efficacy and safety of this combination regimen in patients with high YWHAB expression. The study's primary objective is to assess the tumor downstaging rate, a crucial measure of treatment success.

Key Takeaways:

• The clinical trial is focused on patients with locally advanced rectal cancer and high YWHAB expression, a biomarker-enriched population identified through immunohistochemistry or RNA-seq.
• The study will assess the efficacy of the neoadjuvant therapy with mFOLFOX6 combined with citrus flavonoid tablets (Aimailang) in terms of tumor downstaging rate, pathological complete response rate, and 3-year disease-free survival.
• Safety assessments will evaluate the incidence of Grade 3 or higher treatment-related adverse events, such as hematologic, gastrointestinal, and neurotoxicities.
• The trial will enroll patients and collect data on treatment outcomes, including overall survival and tumor regression grading.

Statistics:

• Primary Objective: Evaluate the tumor downstaging rate (ypTNM 0-I stage) in patients with YWHAB-overexpressing locally advanced rectal cancer (LARC) receiving neoadjuvant therapy with mFOLFOX6 combined with citrus flavonoid tablets (Aimailang).
• Secondary Objectives: Assess efficacy through pathological complete response rate, 3-year disease-free survival, overall survival, and tumor regression grading; evaluate safety through incidence of Grade 3 or higher treatment-related adverse events.

Sources:

• Chinese Clinical Trial Registry (ChiCTR), registration number: ChiCTR2500107086
• Chinese National Medical Product Administration (CNMPA)