Actively Recruiting
Total Neoadjuvant Therapy With Induction Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by National Taiwan University Hospital · Updated on 2026-01-27
50
Participants Needed
1
Research Sites
52 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
Researchers are evaluating a total neoadjuvant therapy approach for patients with locally advanced esophageal squamous cell carcinoma (ESCC). This study aims to improve outcomes by combining induction immunochemotherapy with chemoradiotherapy before surgery. The treatment involves using anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors plus cisplatin-based chemotherapy, which has shown promise in late-stage ESCC by increasing tumor response and survival. Participants receive induction immunochemotherapy including Tislelizumab, Paclitaxel, and Cisplatin administered intravenously every three weeks for two cycles. This is followed by chemoradiotherapy consisting of weekly doses of Paclitaxel and Cisplatin along with radiation therapy delivered five days a week for 25 sessions. After these treatments, surgery is performed to remove the tumor. Throughout the study, participants are closely monitored with assessments including pathological response to treatment measured over an average of six months. Researchers will evaluate outcomes such as disease-free survival, event-free survival, distant metastasis rates, and overall survival for up to 50 months. Safety and disease recurrence are also tracked. Participation lasts through treatment, surgery, and follow-up to understand the therapy's impact on tumor control and survival.
CONDITIONS
Brief 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 as defined by TNM criteria: cT3/4a, N0, M0 or cT1-4a, N1-3, M0
- Tumor length longitudinally ≤ 10 cm and radially ≤ 5 cm
- Tumor extension into stomach no more than 2 cm
- No invasion of tracheobronchial tree or presence of tracheoesophageal fistula
- Age between 18 and 75 years
- ECOG performance status 0 to 1
- Adequate bone marrow reserves (WBC ≥ 3,000/µl or ANC ≥ 1,500/µl; platelets ≥ 100,000/µl)
- Adequate liver function (hepatic transaminases ≤ 2.5 x ULN; total bilirubin ≤ 2.0 x ULN)
- Adequate renal function (creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min)
- Written informed consent
- Negative pregnancy test within 72 hours before first study medication dose for females of childbearing potential
- Willingness to use adequate contraception during study and for 120 days after last dose (both females and males of childbearing potential)
You will not qualify if you...
- Diagnosis of adenocarcinoma
- Previous thoracic irradiation
- Previous systemic chemotherapy
- Prior therapy with anti-PD-1 or anti-PD-L1 agents
- Synchronous squamous cell carcinoma in aerodigestive tract other than esophagus
- Prior malignancy except adequately treated skin cancer, in-situ cervical cancer, or cured malignancy >5 years prior
- Significant co-morbid diseases prohibiting treatment or surgery
- Recent myocardial infarction within 6 months or serious cardiac arrhythmias
- Pre-existing motor or sensory neurotoxicity greater than grade 1
- Allergic reactions to drugs containing Cremophor
- Weight loss greater than 15%
- Dementia or mental status preventing informed consent
- Life expectancy less than 3 months
- Immunodeficiency or recent immunosuppressive therapy within 7 days prior to treatment
- Active tuberculosis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or evidence of pneumonitis, interstitial lung disease, or pulmonary fibrosis
- Pregnancy, breastfeeding, or expecting to conceive/father children during study and 120 days after
- Known HIV infection
- Untreated chronic hepatitis B or active hepatitis C
- Live vaccine within 30 days before study therapy
- History of organ transplantation
- Declined esophagectomy surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive neoadjuvant immunochemotherapy with Tislelizumab, Paclitaxel, and Cisplatin administered every 3 weeks for 2 cycles.
2 visits (in-person) every 3 weeks
Duration - 5 weeks
Participants receive chemoradiotherapy with Paclitaxel and Cisplatin on days 1, 8, 15, 22, and 29 combined with radiation therapy given 5 days a week for 5 weeks.
5 weekly visits for chemotherapy and daily visits for radiation therapy (Monday to Friday) for 5 weeks
Duration - 1 day
Participants undergo esophagectomy surgery to remove the tumor after completing chemoradiotherapy.
1 visit (in-person) for surgery
Duration - Up to 50 months
Participants are monitored for recovery and assessment of surgical outcomes including pathological response and survival.
Periodic visits as per clinical care
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
C
Chien-Huai Chuang, M.D.
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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