By InvitationNot Applicable

A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma

China40 participantsStarted 2023-11-29

Plain-language summary

The goal of observational study is to learn about the outcomes of the participants. The main questions it aims to answer are: 1. ESD additional postoperative radiotherapy in patients with non healing SESCC overall survival (OS) and disease-free survival (DFS) 2. The adverse events (AE) of additional radiotherapy after ESD for non-curative SESCC patients were counted, and its safety was evaluated. Participants will receive radiation therapy as necessary.

Who can participate

Age range

18 Years – 75 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: * (1) patients with esophageal squamous cell carcinoma within pT1 (stage pT1N0M0) confirmed by pathology; * (2) The following conditions were confirmed by pathology after ESD: submucosal invasion \> 200μm (stage SM2-SM3), undifferentiated or poorly differentiated pathological degree, positive surgical margin, vascular and lymphatic invasion; * (3) aged 18-75 years old (inclusive); * (4) predicted survival time ≥6 months; * (5) ECOG score of 0-1; * (6) no obvious other symptoms or no effect assessed by researchers; * (7) Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose. Male or female patients of childbearing potential volunteered to use an effective contraceptive method, such as dual barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study and for 90 days after the last study medication was taken. All female patients will be considered fertile unless the woman has undergone natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnexectomy); * (8) Electrocardiogram, blood, biochemical and other basic examinations had no contraindications to radiotherapy, and had sufficient bone marrow, liver and kidney organ functions. Laboratory examinations within 7 days before the first dose of medication met the following requirements: a. Absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L and hemoglobin ≥90g/L (no…

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.

What they're measuring

Overall Survival, OS

Timeframe: It continued for 3 years after enrollment

Disease Free Survival, DFS

Timeframe: It continued for 3 years after enrollment

Trial details

NCT IDNCT06160557

SponsorXiaomeng Zheng

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-01

View on ClinicalTrials.gov More Esophagus Cancer trials