Actively Recruiting
A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Army Medical Center of PLA · Updated on 2024-04-09
266
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.
CONDITIONS
Official Title
A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma confirmed by histology or cytology
- Ability to take anlotinib capsules orally
- No previous systemic antitumor treatment
- ECOG performance status of 0 to 1
- Adequate organ function including neutrophil count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥80×10^9/L, total bilirubin ≤1.5 times the upper limit of normal, normal serum creatinine, and ALT/AST ≤2.5 times the upper limit of normal
- No incurable serious complications or major diseases
- Assessed by thoracic surgeon as able to tolerate surgery
- Medically approved contraception required for female participants of childbearing potential and male participants with partners during treatment and for at least 6 months after last chemotherapy
- Voluntary informed consent and willingness to comply with study and follow-up
You will not qualify if you...
- Body mass index less than 18.5 kg/m2 or more than 10% weight loss in 2 months before screening
- Tracheal, bronchial, or major vascular invasion; deep esophageal ulcers; digestive tract perforation, fistula, or major bleeding; poor lung function or chronic lung disease within 6 months before treatment
- Significant feeding obstruction preventing oral anlotinib use
- Known allergy to any biological agent, PD-1 monoclonal antibody, albumin-bound paclitaxel, carboplatin, or platinum drugs produced by Chinese hamster ovary cells
- Prior treatment with investigational drugs, enrollment in other clinical trials (except observational), or prior anti-tumor or live vaccine treatment
- History of active autoimmune diseases or immunodeficiency (including HIV infection), organ or bone marrow transplantation
- Uncontrolled cardiovascular symptoms or diseases
- Active hepatitis B, hepatitis C, or pulmonary tuberculosis
- Severe infection within 4 weeks before treatment or active lung inflammation or infection within 2 weeks before treatment requiring antibiotics
- Major surgery within 28 days before treatment or planned major surgery during study
- Other malignancies within 5 years except low-risk skin or cervical cancers
- Pregnancy, breastfeeding, or inability/refusal to use contraception
- Other factors per investigator discretion that may require study termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Army Medical Center of PLA
Chongqing, None Selected, China
Actively Recruiting
Research Team
M
Mengxia Li
CONTACT
X
Xiao Yang
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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