Actively Recruiting
Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-03-11
46
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Patients will be treated with serplulimab, nimotuzumab plus concurrent chemoradiotherapy (41.4Gy/1.8Gy/23F) . Six to eight weeks after the completion of neoadjuvant chemoradiotherapy, patients who are considered operable by surgeons will undergo radical resection of esophageal cancer. Postoperative pathological assessment includes MPR rate, pCR rate, and pathological response grade, etc. This trial aims to explore the safety and efficacy of adding serplulimab and nimotuzumab to neoadjuvant chemoradiotherapy, with a focus on whether the combined treatment regimen can enhance the efficacy and safety of neoadjuvant chemoradiotherapy.
CONDITIONS
Official Title
Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 75 years, any gender
- Histologically confirmed locally advanced thoracic esophageal squamous cell carcinoma (clinical stage cT1N2-3M0 or cT2-4aN0-3M0)
- ECOG performance status 0-1
- Expected to achieve complete tumor removal (R0 resection)
- No prior treatment for primary esophageal tumor including drugs, surgery, or radiation
- No suspicious metastatic lymph nodes in the neck or systemic metastasis on imaging
- Measurable lesions per RECIST 1.1 criteria
- Adequate blood counts: absolute neutrophil count ≥ 1.5×10^9, platelets ≥ 80×10^9, hemoglobin ≥ 90 g/L
- Liver function: total bilirubin ≤ 1.5× upper limit normal, AST and ALT ≤ 2.5× upper limit normal (≤ 5× if liver metastasis)
- Kidney function: serum creatinine ≤ 1.5× upper limit normal or creatinine clearance ≥ 60 ml/min
- Serum albumin ≥ 28 g/L
- Heart function: left ventricular ejection fraction ≥ 50%
- Lung function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% predicted, DLCO ≥ 80% predicted
- Women of childbearing potential must use contraception during and for 6 months after study and have a negative pregnancy test within 7 days before enrollment; must not be breastfeeding
- Men must agree to use contraception during and for 6 months after study
- Able to understand and sign informed consent
You will not qualify if you...
- Use of EGFR monoclonal antibodies or EGFR-TKIs within the past 6 months
- Participation in other interventional clinical trials within 30 days before screening
- Severe comorbidities such as heart failure, uncontrolled arrhythmias, severe myocardial infarction, refractory hypertension, stage 4 or higher kidney failure, thyroid dysfunction, mental disorders, diabetes, severe chronic diarrhea, or judged unsuitable by investigator
- Brain metastases with symptoms or controlled for less than 3 months
- History of other cancers except cured in situ cervical cancer or basal cell carcinoma, or other cancers cured more than 5 years ago
- Active infection or infectious disease
- Multiple esophageal tumors or signs of esophageal fistula or perforation
- Tumor invasion of important blood vessels or high risk of fatal bleeding as judged by investigator
- Allergy to study drugs or their components
- Peripheral neuropathy or hearing loss grade 2 or higher
- Pregnant or breastfeeding women
- History of psychiatric drug abuse or untreated mental disorders
- Deemed unsuitable for study by investigator
- Unwilling or unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
L
Lei Gong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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