• Ziqi Yue, PharmD

Advances in U.S. Colorectal Cancer Clinical Trials

In China, colorectal cancer is the third most common cancer among women and the fourth most common cancer among men (Global Health Journal, 2018). Surgery is the standard treatment for early-stage colorectal cancer from stage 0 and stage 1, when the cancer has not spread into nearby tissue or lymph nodes (American Cancer Society, 2020).Unfortunately, the majority of patients in China are diagnosed at advanced stages of colorectal cancer since the symptoms are often subtle and may be difficult to notice in early stages. In fact, many colon cancer patients may only have mild symptoms until the cancer has become significantly advanced.

Cancer starts with one or several gene mutations in the human body. Deficient DNA mismatch repair is one of the common causes of colorectal cancer. DNA mismatch repair is a system in the body to identify and fix DNA mutations. Deficient DNA mismatch repair will deactivate the mutation repair system in the body and can lead to multiple diseases, including colon cancer (Human Molecular Genetics, 2001).

There are a number of clinical trials focused on new colon cancer treatment and therapies. In one clinical trial, the National Cancer Institute is investigating the efficacy of the combination of standard chemotherapy with an immunotherapy drug called Tencentriq® (atezolizumab) in stage 3 colon cancer patients with DNA mismatch repair deficiency. Chemotherapy works in different ways to stop tumor cell growth, while Tencentriq® helps the body’s immune system attack cancer. This phase 3 trial is investigating if the combination involving immunotherapy is more effective than chemotherapy alone. It is estimated 700 participants have enrolled and expected to be completed in December 2020 (, 2020).

A recent study revealed that 48.9% of Chinese colorectal patients were detected with gene mutations. The KRAS gene is the most common gene mutation among all Chinese colorectal cancer patients (Cancer Medicine, 2020). It is responsible for making a specific protein in the human body, which functions as a switch for cell growth and division. Mutation in this gene may permanently turn on the switch. Therefore, the mutated KRAS gene may lead to colon cancer cases that are aggressive and more difficult to treat (Journal of Medicine and Life, 2014).

Onvansertib is one of the investigational drugs targeted towards patients who have unresectable metastatic colorectal cancer with a KRAS mutation. The ongoing phase 1b/2 trial is evaluating the safety and efficacy of onvansertib in combination with chemotherapy and targeted therapy as the second preferable treatment regimen for patients (, 2020). On May 28, 2020, FDA granted Fast Track designation to onvansertib, thus expediting the drug’s review (Cardiff Oncology, 2020).

Want to learn more about colorectal clinical trials and new colon cancer treatments in the U.S.? Contact RangeLight Health today to receive a second opinion from a top U.S.-based colorectal cancer expert.

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