Actively Recruiting
Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma
Led by Henan Cancer Hospital · Updated on 2022-10-04
400
Participants Needed
1
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.
CONDITIONS
Official Title
Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of locally advanced thoracic esophageal squamous cell carcinoma, Stage T1N1-3 or T2-3N0-3 M0
- No metastatic lymph nodes in cervical region by color doppler sonography
- No prior anticancer therapy for esophageal carcinoma
- Age between 18 and 75 years
- No contraindications for surgery
- Adequate blood counts and normal liver and kidney function tests
- No diagnosis of other cancers except prostate cancer with more than 5 years disease-free survival
- Expected to achieve complete tumor removal (R0 resection)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Agree to use contraception during the study and for 6 months after
- Women must not be breastfeeding
- Signed informed consent
You will not qualify if you...
- Multiple primary cancers
- Active infections requiring treatment
- Need for continuous hormone treatment
- Unstable angina within 3 months or myocardial infarction within 6 months
- Psychiatric disorders
- Hemorrhagic diseases
- Any reason preventing surgery
- Inability to use gastric conduit after esophagectomy due to prior surgery
- Pregnant or breastfeeding women
- Allergy or suspected allergy to cisplatin or paclitaxel
- Bronchial asthma requiring intermittent bronchodilators or medical interventions
- Use of immunosuppressants above specified doses within 2 weeks before enrollment
- Abnormal coagulation or bleeding tendency, or receiving anticoagulant therapy
- Previous or present lung diseases severely impairing lung function
- Autoimmune diseases, immune deficiency, or organ transplantation
- Hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
Y
Yan Zheng, PhD, MD
CONTACT
H
Haibo Sun, PhD, MD
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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