Actively Recruiting
Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma
Led by National Taiwan University Hospital · Updated on 2026-01-27
50
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis. Collectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the intrathoracic esophagus.
- Locally advanced disease defined by AJCC (8th edition) TNM staging: cT3/4a, N0, M0 or cT1-4a, N1-3, M0.
- Tumor length longitudinal ≤ 10 cm and radial ≤ 5 cm.
- Tumor must not extend more than 2 cm into the stomach.
- No invasion of the tracheobronchial tree or tracheoesophageal fistula.
- Age between 18 and 75 years.
- ECOG performance status of 0 to 1.
- Adequate bone marrow function: WBC ≥ 3,000/μl or ANC ≥ 1,500/μl; platelets ≥ 100,000/μl.
- Adequate liver function: hepatic transaminases ≤ 2.5 times ULN; total bilirubin ≤ 2.0 times ULN.
- Adequate renal function: creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 ml/min.
- Written informed consent.
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose and agree to use contraception during the study and for 120 days after last dose.
- Male participants of childbearing potential must agree to use contraception during the study and for 120 days after last dose.
You will not qualify if you...
- Diagnosis of adenocarcinoma.
- Previous thoracic radiation therapy.
- Previous systemic chemotherapy.
- Prior treatment with anti-PD-1 or anti-PD-L1 agents.
- Synchronous squamous cell carcinoma in the aerodigestive tract other than esophageal cancer.
- Prior malignancies except adequately treated basal or squamous cell skin cancer, in-situ cervical cancer, or cured malignancy more than 5 years ago.
- Significant co-morbidities preventing immunochemotherapy, CRT, or surgery.
- Myocardial infarction within 6 months before registration or significant heart arrhythmias or heart block.
- Pre-existing motor or sensory neurotoxicity greater than grade 1.
- Allergic reactions to drugs containing Cremophor.
- Weight loss greater than 15%.
- Dementia or altered mental status preventing informed consent.
- Life expectancy less than 3 months.
- Immunodeficiency or recent immunosuppressive therapy within 7 days before treatment.
- Active tuberculosis.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- Active non-infectious pneumonitis, interstitial lung disease, or pulmonary fibrosis.
- Pregnancy, breastfeeding, or planning to conceive or father children during study and 120 days after last dose.
- HIV infection.
- Untreated or active chronic hepatitis B or active hepatitis C.
- Live vaccine within 30 days before starting study therapy.
- Organ transplantation.
- Declined esophagectomy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100229
Actively Recruiting
Research Team
C
Chih-Hung Hsu, M.D., PhD
CONTACT
C
Chien-Huai Chuang, M.D.
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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