A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer (NCT03213054) | Clinical Trial Compass
UnknownPhase 1
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
Japan12 participantsStarted 2017-07-07
Plain-language summary
This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.
Who can participate
Age range
20 Years – 89 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
. Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
. Patients are feasible for injection of OBP-301 into target legion
. Patients aged in 20 to 89 years.
. Patients with ECOG Performance Status Score ≤ 2.
. Patient who have life expectancy longer than 12 weeks.
. Patients who are not applicable to standard therapy.
. Patients who have adequate organ function.
Exclusion criteria
. Patients who have an active, treatment-required concomitant malignancy.
. Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
. Patients who have had chemotherapy within 4 weeks.
. Patients who have treatment history of cancer immunotherapy.
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.