A clinical trial is a systematic study of a drug in humans (patients or healthy volunteers) to confirm or reveal the action, adverse effects, absorption, distribution, metabolism, and excretion of the test drug, with the goal of determining the efficacy and safety of the test drug. This article takes a look at who can participate in clinical trials and what types of clinical trials are available to patients with gastric cancer.
Who can participate in clinical trials?
Who can participate in a clinical trial?
Who can participate in a clinical trial?
The ability to participate in a clinical trial depends on the trial’s inclusion criteria, which are the conditions that need to be met to be allowed to participate in the trial, and exclusion criteria, which are factors that are not allowed if certain factors are present. These criteria are established before the trial begins and usually include age, gender, type and stage of disease, treatment history, other comorbid conditions, etc. In summary, such a population may be allowed to participate in a clinical trial only if it meets the inclusion criteria and does not meet the exclusion criteria. The population enrolled in a clinical trial may be patients or healthy individuals.
What does it mean for patients to participate in a clinical trial?
Clinical trials represent the latest treatment directions for a disease, and generally the treatments being tested have been rigorously demonstrated in in vitro and animal studies. For some patients, participation in a clinical trial has the following significant implications.
- Early access to new therapies or new drugs that are not yet on the market. By receiving these new treatments in trials, patients may have better outcomes, and there is certainly new hope, especially for cancer patients whose disease progression cannot be controlled with existing treatments.
- Patients in the trial may not be assigned to the new therapy or new drug treatment group and may receive the current standard therapy. That is, patients will not receive therapies in the trial that are less effective than the treatments they receive in the routine.
- Most clinical trials are free, so participation in a clinical trial can greatly reduce the financial burden on patients.
- Patients can be closely monitored and supervised by the medical team involved in the clinical trial, which can help to improve treatment outcomes.
In addition, participation in a clinical trial may not only benefit you, but it is a contribution to medicine that will potentially benefit more patients in the future.
What are the risks for patients participating in a clinical trial?
A clinical trial is ultimately an attempt at a new type of treatment, and with the benefits that come with it, there are some risks for patients, mainly in the following two areas.
- New treatments are not necessarily better than the treatments you receive every day.
- Newer treatments may have some adverse effects that have not been encountered before.
What does a clinical trial of gastric cancer treatment involve?
Early gastric cancer
Early gastric cancer generally has better outcomes after standardized treatment. Therefore, the goal of clinical trials for early gastric cancer is mainly to minimize trauma and improve postoperative quality of life with the premise of radical treatment. Current clinical trials for early gastric cancer include two main directions:
- To explore the relevant indications for endoscopic treatment of early gastric cancer;
- For early gastric cancer that cannot be treated endoscopically, explore the role of laparoscopic surgery in the treatment of early gastric cancer, and try to be minimally invasive while ensuring radical treatment.
Locally progressive gastric cancer
The focus of clinical trials in locally progressive gastric cancer is to improve the degree of tumor eradication, prolong survival, and improve final outcomes. Clinical trials for this group of patients involve the following:
- Scope of surgery, which explores the extent of lymph node dissection for gastric cancer;
- Comprehensive treatment, aiming to further improve the treatment of locally progressive gastric cancer based on surgery, involving preoperative neoadjuvant therapy, postoperative adjuvant therapy, and specifically treatment methods including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
Advanced gastric cancer
Surgery is still the only means of curing gastric cancer, and radical resection of advanced gastric cancer is usually no longer possible through surgery.
The field of gastric cancer is exploring translational therapy in an attempt to reverse tumor progression early in gastric cancer with distant metastases, converting patients to be surgically curable. Currently, translational therapy for gastric cancer is focused in three directions: liver metastases, abdominal metastases, and station 3 lymph node metastases.
In summary, clinical trials play an important role in advancing the treatment of gastric cancer in an era of new drugs and therapies. Although some national guidelines can provide targeted treatment advice to guide physicians based on current findings, guidelines are still relatively conservative, and more and further clinical trials are needed to answer the question of how some of the newer therapies and drugs actually work.