Efficacy of Chemoradiotherapy Versus Adjuvant Esophagectomy for Patients with Clinical Stage N0M0 and Pathological Stage T1b Esophageal Squamous Cell Carcinoma After Endoscopic Submucosal Dissection: A pragmatic, prospective, noninferiority, non-randomized controlled trial

Efficacy of Chemoradiotherapy Versus Adjuvant Esophagectomy for Patients with Clinical Stage N0M0 and Pathological Stage T1b Esophageal Squamous Cell Carcinoma After Endoscopic Submucosal Dissection: A pragmatic, prospective, noninferiority, non-randomized controlled trial - EndoSurgery01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083321

Enrollment

Unknown

Registered

2024-04-22

Start date

2024-04-30

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Simultaneous chemoradiotherapy group:Simultaneous chemoradiotherapy

Surgery group:esophagectomy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18-80 years old; 2) without lymph node metastasis or distant metastasis on imaging; 3) Stage T1b esophageal squamous cell carcinoma (infiltrating into the submucosa) with negative vertical margin confirmed by pathology after ESD; 4) without preoperative neoadjuvant therapy or targeted therapy; 5) signed informed consent.

Exclusion criteria

Exclusion criteria: 1) personal history of synchronous or metachronous (within 5 years) malignant tumors; 2) patients who could not tolerate surgery or radiotherapy or chemotherapy due to severe heart and lung diseases or severe renal insufficiency; 3) pregnant and lactating women; 4) patients with a history of myocardial infarction within 6 months; 5) patients with a history of cerebral infarction or cerebral hemorrhage within 6 months

Design outcomes

Primary

Measure	Time frame
overall survival rate;	—

Secondary

Measure	Time frame
progress-free survival;overall survival;progress-free survival;Life quality evaluation;	—

Countries

China

Contacts

Public ContactPinghong Zhou

Zhongshan Hospital, Fudan University

zhou.pinghong@zs-hospital.sh.cn+86 136 8197 1063

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026