Clinical Trials in Stomach Cancer

Clinical trials are research studies that are testing new drugs, already approved drugs, medical devices or other forms of medicine and/or surgery in people. These trials are the main method through which scientists and doctors discover new and/or improved ways to prevent, diagnose and treat all sorts of diseases, including cancer.

Clinical trials have various different objectives, such as:

• Testing a new drug, treatment or combination to learn if it is more effective or poses less harmful side effects than existing therapies
• Testing ways of diagnosing diseases like stomach (or gastric) cancer early, sometimes before any symptoms appear
• Finding approaches to prevent health problems, including in people with an elevated risk of developing a disease
• Improving the quality of life for people that have a life-threatening disease or chronic health problem

Before the start of human clinical trials are preclinical studies, which typically involve tests done on cells grown in the lab and subsequently on cancers in live animals. If you come across the clinical trials mentioning the following terms, it is in reference to such test settings.

• in situ — in its original place (referring to the cancer’s site of origin within the gastric tissue)
• in vitro — in glass; outside the body; in a laboratory
• in vivo — in (something) living; in/on a living organism

Preclinical findings need to suggest that the new drug or device is lPreclinical findings need to suggest that the new drug or device is likely to be safe and will work in people before clinical trials can commence.

Clinical trials move through four consecutive phases that build on one another. They are designed to test safety, ascertain effectiveness and pinpoint any side effects related to the drug or medical device. The United States Food and Drug Administration (FDA) usually requires Phase 1, 2 and 3 trials to be conducted in order to deem the drug or device safe and effective, after which it can be approved for clinical use.

If you’re opting for a clinical trial, knowing what each phase entails is important. It can give you an idea of how much information is known about the treatment being studied. Each phase has a different purpose, such as:

• Phase 1: This phase of the trials tests an experimental drug or device on a small group of approximately 20 to 80 people. The aim is to determine its safety and to test the appropriate dosage. The latter is done by finding the highest dose of the new drug or device that can be administered safely without causing severe side effects. This process is done gradually; the first few study participants receive a very low dose and are watched closely before the dose is increased.
  
• Phase 2: The aim of phase 2 trials is to collect information on whether the drug or device is effective. This could be in terms of shrinking the cancer, prolonging the recipient’s survival, or other benefits (depending on the goal that the intervention seeks to achieve). It typically involves more people (in the hundreds) receiving the dose or method found to be the safest and most effective in phase 1 trials.
  
  Sometimes, Phase 2 studies are divided into Phase 2a and 2b. Phase 2a is designed specifically to assess optimal dosing and safety (how much of the drug should be given), while Phase 2b is designed to examine the efficacy of the drug (how well the drug works at the prescribed dose(s)).
  
• Phase 3: This phase compares the safety and effectiveness of the intervention against the current standards of care. Study participants are often randomly assigned to get either the standard, or the new drug or device. Phase 3 trials often involve several hundred to a few thousand people in different populations. If the FDA deems that the trial results support the intervention’s use, it typically approves the experimental drug or device.
  
• Phase 4: Phase 4 trials take place after FDA approval, monitoring the effectiveness and safety of the drug or device in large, diverse populations. This is because side effects, especially rare ones, may not become clear until a larger group of people has used the intervention over a longer period of time. Phase 4 trials may also look at other aspects of the drug or device, such as cost-effectiveness or its effects on quality-of-life.

Clinical trials are ongoing for various types of cancer, including cancers of the stomach. Some aspects of gastric cancer that research is looking into include:

• Causes of gastric cancer: Some trials are studying the causes of gastric cancer, such as genetic changes in people who are diagnosed with gastric cancer at a young age or have a family history of gastric cancer.
• Diagnosis of gastric cancer: Because gastric cancer is known for only causing symptoms at the later stages, researchers are always trying to find new tests that can help to detect gastric cancer at an early stage, before symptoms even appear.
• Treatment of gastric cancer: Researchers across the globe are testing various drugs and drug combinations that can be used in gastric cancer. This is to see if they might cause fewer side effects, work better with other cancer drugs or reduce the likelihood of gastric cancer coming back.

If you’re in the US and interested to find out more about clinical trials in gastric cancer, the following websites will have further information:

• Stomach Cancer Clinical Trials by Mayo Clinic.
• ClinicalTrials.gov. This U.S. government database lists clinical trials that are publicly and privately supported.
• World Health Organization (WHO) International Clinical Trials Registry Platform. This search portal gathers clinical trial information from the registries of numerous countries.
• Stomach Cancer Clinical Trials under the purview of No Stomach for Cancer
• Stomach cancer clinical trials at University of California, San Francisco (UCSF)
• Clinical Trials for Stomach Cancer at Siteman Cancer Center
• Stomach Cancer Clinical Trials at University of Los Angeles (UCLA)
• CenterWatch Clinical Trials Listing Service