Actively Recruiting
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Henan Cancer Hospital · Updated on 2024-10-02
219
Participants Needed
2
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
CONDITIONS
Official Title
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven squamous cell carcinoma
- Tumors located in the thoracic esophagus
- Age between 18 and 70 years
- ECOG performance status of 0 or 1
- Resectable cT1-4aN+M0 or T3-4aN0M0 disease with residual disease after neoadjuvant chemotherapy plus surgery, or cT1-2N0M0 with pathologically proven T1-2N+M0 after upfront surgery
- No metastatic cervical lymph nodes
- R0 resection achieved by minimally invasive esophagectomy or open McKeown approach with total two-field or three-field lymph node dissection
- No prior therapy for other cancers
- Adequate bone marrow function: white blood cell count ≥ 4×10^9/L; absolute neutrophil count ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 9 g/dl
- Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal; AST and ALT ≤ 2.0 × upper limit of normal
- Adequate renal function: glomerular filtration rate ≥ 60 ml/min (Cockcroft-Gault formula)
- Normal thyroid function
- Written informed consent obtained
You will not qualify if you...
- Received neoadjuvant chemoradiation therapy
- Pathological complete response (pCR)
- Fewer than 15 lymph nodes dissected
- Clinical stages T1-2N+M0 who received upfront surgery
- Unresectable disease including bulky metastatic lymph nodes or T4b after induction chemotherapy
- Need for systemic steroid medication
- Severe postoperative complications making adjuvant therapy unsuitable
- Synchronous or metachronous double cancers within 5 years
- Prior immunotherapy
- Active infection requiring systemic therapy
- History of organ transplant or allogenic hematopoietic stem cell transplantation
- Human immunodeficiency virus (HIV) infection
- Psychiatric disease
- Pregnant or lactating women or women of childbearing potential
- Hypersensitivity to Sintilimab
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
H
Haibo Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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