Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03791905
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
3. Not suitable for surgery (either for medical reasons or patient's choice);
4. Age at diagnosis 18 to 70 years;
5. Eastern Cooperative Oncology Group performance status ≤ 2
6. No prior cancer therapy;
7. No history of concomitant or previous malignancy;
8. Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
9. Renal function: Cr ≤ 1.25×UNL;
10. Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
11. Documented informed consent to participate in the trial.
Exclusion Criteria:
1. Younger than 18 or older than 70 years of age;
2. ECOG performance status of 3 or above;
3. Other cancer history;
4. Previous radiotherapy history;
5. Subjects with distant metastases;
6. Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
7. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
8. Evidence of bleeding diathesis or serious infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03791905
Study Brief:
Protocol Section:
NCT03791905