Actively Recruiting
Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Army Medical Center of PLA · Updated on 2024-04-09
266
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of two different preoperative treatments for patients with locally advanced esophageal squamous cell carcinoma. It compares neoadjuvant immunotherapy combined with chemotherapy and anlotinib to immunotherapy combined with concurrent chemoradiotherapy. The study is a single-center, open-label, randomized controlled trial designed to find the best preoperative treatment approach for this type of esophageal cancer. Participants will receive one of two treatment regimens before surgery. One group receives camrelizumab, chemotherapy drugs (carboplatin, cisplatin, paclitaxel or nab-paclitaxel), and oral anlotinib over two 3-week cycles. The other group receives camrelizumab, chemotherapy drugs, and thoracic radiotherapy given daily over about 4.6 weeks during the same period. Both treatments are given before surgery to shrink the tumor. During the study, participants will be monitored for pathological response up to approximately 15 weeks after randomization. Researchers will assess tumor response using pathological complete response and major pathological response measures. Secondary outcomes include objective response rate, 3-year disease-free survival, R0 excision rate, and overall survival. The study lasts up to about 3 years after surgery to track long-term outcomes and safety.
CONDITIONS
Brief 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 systematic antitumor treatment
- ECOG performance status 0-1
- Adequate organ function including neutrophil count ≥1.5×10^9/L, platelets ≥80×10^9/L, hemoglobin ≥80×10^9/L, total bilirubin ≤1.5× upper limit of normal, normal serum creatinine, ALT and AST ≤2.5× upper limit of normal
- No incurable serious complications or major diseases
- Surgery deemed tolerable by thoracic surgeon
- Medically approved contraception for females of childbearing potential and males with partners of childbearing potential during study and for 6 months after last chemotherapy
- Voluntary informed consent and willingness to comply with study and follow-up requirements
You will not qualify if you...
- Body mass index under 18.5 kg/m2 or 10% weight loss in 2 months before screening
- Tracheal, bronchial, or major vascular invasion; deep esophageal ulcer; digestive tract perforation or fistula; major bleeding; poor lung function or chronic lung disease within 6 months prior to study drug
- Significant feeding obstruction preventing oral anlotinib intake
- Known allergy to components of biological or PD-1 monoclonal antibody formulations, albumin-bound paclitaxel, carboplatin, or platinum drugs from Chinese hamster ovary cells
- Previous investigational drug use or anti-tumor/live vaccine treatments; current enrollment in other clinical studies except observational
- History of active autoimmune diseases
- History of immunodeficiency including positive HIV, congenital or acquired immune disorders, or organ/bone marrow transplantation
- Uncontrolled cardiovascular disease
- Active hepatitis B or C infection or active pulmonary tuberculosis
- Severe infection (CTCAE > 2) within 4 weeks before study drug; active lung inflammation or infection signs within 2 weeks before study drug requiring antibiotics
- Major surgery within 28 days before treatment or planned during study
- Other malignancies diagnosed within 5 years except low-risk skin or cervical cancers
- Pregnancy or lactation; refusal or inability to use contraception
- Other factors judged by investigator as requiring study termination
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 to 7 weeks
Participants receive neoadjuvant immunotherapy combined with chemotherapy and anlotinib or immunotherapy combined with concurrent chemoradiotherapy before surgery.
2 cycles of treatment with visits every 3 weeks; radiation delivered daily 5 days/week for 4.6 weeks in one arm
Duration - Up to approximately 15 weeks after randomization
Participants are followed up after completion of neoadjuvant treatment and surgery to monitor safety and efficacy outcomes.
Visits scheduled as per study protocol during follow-up period
Trial Site Locations
Total: 1 location
1
Army Medical Center of PLA
Chongqing, None Selected, China
Actively Recruiting
Research Team
M
Mengxia Li
X
Xiao Yang
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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