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Prophylactic Chemoradiotherapy Versus Surveillance After Endoscopic Resection for Early Esophageal Squamous Cell Carcinoma: A Multicenter Randomized Trial

Efficacy of Prophylactic Chemoradiotherapy After Endoscopic Submucosal Dissection in Patients With T1a-MM/T1b-SM1 Lymphovascular-Negative Esophageal Squamous Cell Carcinoma: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117581
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage Esophageal Squamous Cell Carcinoma

Interventions

Prophylactic chemoradiotherapy group:Prophylactic chemoradiotherapy after ESD
Active surveillance group:Active surveillance after ESD

Sponsors

Southern Medical University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Ages 18-80; 2. Pathologically confirmed T1a stage mucosal ESCC (including T1a-MM, T1b-SM1) with negative lymphovascular involvement; 3. No evidence of lymph node metastasis on enhanced chest CT/MRI and/or endoscopic ultrasound (EUS).

Exclusion criteria

Exclusion criteria: 1. Combined esophageal adenocarcinoma or other malignant tumors; 2. Incomplete resection or positive resection margins; 3. Additional surgery after ESD; 4. High-grade intraepithelial neoplasia or ESCC within T1a-LPM; 5. Invasive ESCC T1b-SM2 or deeper; 6. Patients who received radiotherapy, chemotherapy, or surgery before ESD; 7. History of malignant tumors; 8. Pregnancy, severe cardiovascular or pulmonary disease, liver or kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
3?year Disease?Free Survival (DFS);—

Secondary

MeasureTime frame
Cancer Specific Survival (CSS);Overall Survival (OS);Recurrence Rate (RR);Recurrence Pattern;Chemoradiotherapy?Related Adverse Events;Postoperative Complication Rate;—

Countries

China

Contacts

Public ContactGong Wei

Southern Medical University Shenzhen Hospital

gongwei@smu.edu.cn+86 23360650

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026