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C-SMART Trial: Standardization of Proximal Resection Margin in Larynx-Preserving Esophagectomy for Cervical or Cervical-Involving ESCC (Multicenter Prospective Study)

C-SMART Trial: Standardization of Proximal Resection Margin in Larynx-Preserving Esophagectomy for Cervical or Cervical-Involving ESCC (Multicenter Prospective Study)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114745
Enrollment
Unknown
Registered
2025-12-17
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Esophageal carcinoma

Interventions

GroupA:Esophagectomy with Preservation of the Larynx for Cervical Esophageal Squamous Cell Carcinoma

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 18-80 years old, gender is not limited; 2. No previous systemic and local treatment against oesophageal cancer; 3. Squamous cell carcinoma of the oesophagus in the cervical segment or involving the cervical segment (the upper pole of the tumour is above the sternal notch or located within 20cm of the incisura); 4. Resectable lesion after neoadjuvant or conversion therapy (in the absence of the following: T4b tumour with aortic, airway or vertebral invasion, giant fused lymph nodes, presence of distant metastases) 5. The patient does not have bilateral recurrent laryngeal nerve palsy after neoadjuvant or conversion therapy (laryngoscopic confirmation is required); 6. The lateral margin of the primary tumour after neoadjuvant or conversion therapy should be more than 2cm from the lower edge of the cricoid cartilage (corresponding to the level of the oesophageal inlet); 7. ECOG score: 0-1 8. Normal major organ function, i.e., the following criteria are met: (1) Routine blood tests: a. HB >= 90g/L; b. ANC >= 1.5×10^9/L; c. PLT >= 80×10^9/L; (2) Biochemistry tests: a. ALB >= 30g/L; b. ALT and AST =60ml/min; 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= low limit of normal (50%); 10. Women of childbearing potential should be patients who agree that contraception (e.g., intrauterine device, birth control pills, or condoms; negative serum or urine pregnancy test within 7 days prior to study entry and must not be breastfeeding; men should agree that contraception is mandatory during the study period and for 6 months after the end of the study period; 11. Subjects will voluntarily enroll in the study, sign an informed consent form, be compliant, and cooperate with follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Patients with other malignancies within the past five years (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ); 3. Patients with a history of psychotropic substance abuse who are unable to abstain, or those with psychiatric disorders; 4. Patients who have participated in other drug clinical trials within the past four weeks; 5. Severe spinal deformity; 6. Patients with concomitant conditions deemed by the investigator to pose a serious risk to patient safety or compromise study completion (e.g., acute myocardial infarction, cerebral infarction, pulmonary embolism); 7. Individuals deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
The R0 resection rate of the proximal margin;

Secondary

MeasureTime frame
operative time;intraoperative blood loss;other perioperative complications (recurrent laryngeal nerve injury, pulmonary complications, cardiac complications, etc.);

Countries

China

Contacts

Public ContactLi Xiangnan

The First Affiliated Hospital of Zhengzhou University

lxn-2000@163.com+86 135 9250 2553

Outcome results

None listed

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