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

NCT06160557 | Enrolling By Invitation

• 1 other identifier: non-curative ESD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of observational study is to learn about the outcomes of the participants. The main questions it aims to answer are:

1. 1.ESD additional postoperative radiotherapy in patients with non healing SESCC overall survival (OS) and disease-free survival (DFS)
2. 2.The adverse events (AE) of additional radiotherapy after ESD for non-curative SESCC patients were counted, and its safety was evaluated.

Conditions

Esophagus Cancer; Radiotherapy; Endoscopic Mucosal Resection

Keywords

esophageal squamous carcinoma; Radiotherapy; endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (2)

• Overall Survival, OS

  OS is defined as the interval from the date of enrollment to the death of the subject from any cause.

  It continued for 3 years after enrollment

• Disease Free Survival, DFS

  DFS is defined as the interval from the date of enrollment to first disease progression, whichever occurred first.

  It continued for 3 years after enrollment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Among the patients with early esophageal cancer after ESD, the pathological results showed positive surgical margin, lymphovascular invasion, SM2-SM3 stage, or poor pathological differentiation

You may qualify if:

• (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 blood transfusion, blood products, granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days before laboratory tests); b. Serum total bilirubin ≤1.5 times the upper limit of the normal reference range (× ULN); c. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; d. Serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 mL/min, (calculated by Cockcroft/Gault formula) : Female: Ccr= (140-age) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL)) Male: Ccr= (140-age) x body weight (kg) x 1.00 /(72 x serum creatinine (mg/dL)); e. Urine routine examination showed urine protein \< 2+; If urinary protein is ≥2+, 24-hour urinary protein should be less than 1 g; f. Sufficient coagulation function, international normalized ratio (INR) ≤1.5, prothrombin time (PT), activated partial prothrombin time (APTT) ≤1.5 × ULN; If the subject is receiving anticoagulant therapy, as long as the PT is within the prescribed range of anticoagulant drugs;
• (9) patients who know all available treatment options and understand the advantages and disadvantages of each option and are willing to enroll after being fully informed;
• (10) consent to provide tissue examination specimens for further confirmation of pathological grade if necessary;
• (12) have fully understood and voluntarily provided informed consent for the study (prior to any trial-specified procedures) and be able to comply with protocol-specified visits and related procedures.

You may not qualify if:

• (1) growth period on contraception, pregnancy (test positive for drug use before pregnancy) or lactating women;
• (2) patients currently have any disease or condition affect drug absorption, or patients cannot oral medicine;
• (3) patients with other malignant tumors (except well-controlled basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, non-melanoma skin cancer, or lentigo malignant nevus) within the past 5 years or with concurrent systemic malignant tumors;
• (4) Patients with other chronic diseases had contraindications to radiotherapy;
• (5) the presence of any active autoimmune disease requiring systemic treatment or a history of autoimmune disease within the past 2 years, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis, systemic lupus erythematosus, etc. (vitiligo, psoriasis, alopecia, or Graves' disease without systemic treatment within the past 2 years; Only need insulin replacement therapy of patients with type 1 diabetes can be incorporated into); Known primary immunodeficiency disease; For patients with only positive autoimmune antibodies, the presence of autoimmune diseases should be determined according to the investigator's judgment;
• (6) receiving systemic immunostimulant therapy within 4 weeks before the first dose;
• (7) administration of any live or live attenuated vaccine within 4 weeks before the first dose or planned during the study period;
• (8) patients who underwent major surgery (the definition of major surgery referred to grade 3 and grade 4 surgery specified in the "Administrative Measures for the Clinical Application of Medical Technology" implemented on May 1, 2009) or unhealed wounds, ulcers or fractures within 4 weeks before the first medication;
• (9) Patients had drug-uncontrolled hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
• (10) patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigators;
• (11) for the first time 2 months before using this drug has a history of thrombosis or bleeding tendency obviously evidence or patients (\> 30 mL, 2 months bleeding appear hematemesis, black dung, bloody), haemoptysis \> 5 mL (4 weeks) of fresh blood, PICC except caused by blood clots;
• (12) for the first time happened within six months before using this drug arterial thrombosis or deep vein thrombosis; Or had a stroke event and/or transient ischemic attack within 12 months;
• (13) clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before the first dose of medication; Congestive heart failure (New York heart association (NYHA) class 2 or higher. Left ventricular ejection fraction (LVEF) \<50%;
• (14) any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment;
• (15) History of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months before enrollment (superficial venous thrombosis was not considered a "major" thromboembolism);

Sponsors & Collaborators

• Xiaomeng Zheng: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master Degree Candidate

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CN (1)