Actively Recruiting
Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
Led by Tang-Du Hospital · Updated on 2023-08-23
114
Participants Needed
3
Research Sites
491 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
CONDITIONS
Official Title
Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of esophageal squamous cell carcinoma
- Age between 18 and 75 years
- Clinical stage II to IVa disease
- No prior antitumor therapy such as immunotherapy or chemoradiotherapy
- ECOG performance status score of 0 or 1
- Adequate organ function including hemoglobin ≥100g/L, white blood cells ≥4x10^9/L or neutrophils ≥2.5x10^9/L, platelets ≥100x10^9/L
- Liver function within specified limits: total bilirubin ≤1.5 times normal, AST and ALT ≤2.5 times normal
- Normal kidney function or creatinine clearance ≥60 ml/min
- Controlled blood glucose and pulmonary function with baseline FEV1 ≥2L or predicted post-surgery FEV1 >800ml
- No recent myocardial infarction or unstable heart conditions
- Women of childbearing potential must use approved contraception during and 3 months after treatment and have negative pregnancy test
- Male patients with partners of childbearing potential must use effective contraception during and 3 months after treatment
- Signed informed consent form
You will not qualify if you...
- Compound squamous cell carcinoma or other specific histological types
- History of subtotal gastrectomy
- Presence of a second primary cancer
- Evidence of distant metastasis by tumor imaging
- Prior chemoradiotherapy treatment
- Signs of esophageal perforation
- Pregnant women
- Active or history of autoimmune diseases
- Active infections including tuberculosis, hepatitis, or HIV
- Known bleeding disorders or other untreatable diseases
- Conditions increasing risk of complication or interfering with study outcomes
- History of interstitial lung disease or related pulmonary conditions
- Unstable systemic diseases, including severe COPD, uncontrolled hypertension, unstable angina, heart failure, recent myocardial infarction, severe mental disorders, or metabolic diseases
- Gastrointestinal dysfunction or active ulcers
- Previous treatment with anti-PD-1 or anti-PD-L1 antibodies
- Use of investigational drugs within 4 weeks before study drug
- Participation in another clinical study except observational or follow-up
- Use of systemic corticosteroids or immunosuppressive agents within 2 weeks before study drug except specified uses
- Vaccination with live or anti-tumor vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Immunodeficiency diseases or organ transplantation history
- Allergies to study drugs including monoclonal antibodies, albumin paclitaxel, 5-fluorouracil, cisplatin, or platinum-based drugs
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Tangdu Hospital of the Fourth Millitary Medical University
Xi'an, Shaanxi, China, 710038
Actively Recruiting
2
Hongtao Duan
Xi’an, Shanxi, China, 710038
Actively Recruiting
3
Tangdu Hospital, the Air Force Military University
Xi'an, China, 710038
Actively Recruiting
Research Team
X
Xiaolong Yan, MD
CONTACT
H
HongTao Duan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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