Establishment of Individualized Immunotherapy Strategy and Platform Based on Changes of Intestina… (NCT05065515) | Clinical Trial Compass
UnknownNot Applicable
Establishment of Individualized Immunotherapy Strategy and Platform Based on Changes of Intestinal Microbiota
China40 participantsStarted 2021-10-01
Plain-language summary
To explore and analyze the relationship between intestinal flora changes and the efficacy of individualized immunotherapy in patients with upper gastrointestinal cancer, and to find new biomarkers to predict the efficacy of immunotherapy, bringing new breakthroughs in tumor diagnosis and treatment.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18-80 years old, no gender limit;
. BMI index 18.5-23.9kg/m2;
. Patients with esophageal squamous cell carcinoma, gastric adenocarcinoma or gastrointestinal stromal tumor diagnosed by pathology;
. Patients who intend to undergo individualized immunotherapy, who have not undergone surgery in the past;
. Patients with advanced or unresectable upper gastrointestinal tumors according to clinical stage;
. ECOG score: 0-1 points;
. Estimated survival period ≥ 3 months;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. All patients should have measurable or evaluable target lesions;
Exclusion criteria
. Patients with pathological types and primary foci that do not meet the inclusion criteria;
. People who are known to be allergic to macromolecular protein preparations, or to immunological preparations and contrast agents and their preparation components;
. Risk of digestive tract perforation;
. Evidence of distant organ metastasis;
. Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed;
. Have suffered from other malignant tumors;
. History of serious lung or heart disease;
. Have active infection or have fever of unknown cause \> 38.5℃ within 2 weeks prior to randomization (according to the judgment of the investigator, the subjects' fever due to tumor can be included in the study);