Actively Recruiting
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Led by Peking Union Medical College Hospital · Updated on 2025-04-02
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
M
Military 301 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the best neoadjuvant treatment plans for adults with locally advanced esophageal squamous cell carcinoma, a type of esophageal cancer without distant metastasis. Previous studies showed that combining chemotherapy with immunotherapy before surgery led to higher rates of tumor response and was generally safe. This trial aims to explore whether extending immunotherapy cycles and adding radiotherapy can improve outcomes further. Participants will be randomly assigned to one of three groups: two cycles of chemoimmunotherapy followed by surgery, four cycles of chemoimmunotherapy followed by surgery, or four cycles of chemoimmunotherapy plus radiotherapy before surgery. Chemotherapy includes carboplatin and nab-paclitaxel, and immunotherapy uses pembrolizumab. Radiotherapy, when used, is given at 40-45 Gy over 20 sessions, five times a week. During the study, participants will undergo surgery after their assigned neoadjuvant treatment. Researchers will assess pathological response after surgery and monitor survival rates at two and five years. They will also track adverse effects, surgical complications, and disease-free survival. The trial includes long-term follow-up to evaluate the safety and effectiveness of these treatment regimens over time.
CONDITIONS
Brief Title
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18 years or older
- Pathological confirmation of esophageal squamous cell carcinoma
- Tumor evaluated as T3 or resectable T4 without distant metastasis (M0), including cervical or supraclavicular lymph node metastasis (M1a)
- Tumor longitudinal diameter 10 cm or less
- Tumor does not involve the dentate line
- ECOG performance status 0 or 1
- No blood diseases or liver/kidney dysfunction
- Absolute neutrophil count at least 1.5 × 10^9/L
- Platelets at least 100 × 10^9/L
- Hemoglobin at least 11 g/L
- ALT level no more than twice the upper limit of normal
- Total bilirubin no more than 1.5 times the upper limit of normal
- Creatinine clearance rate at least 50 ml/min
- Provided informed consent
You will not qualify if you...
- Tumor staging T1 or T2
- Presence of distant metastasis (M1) by PET/CT or other evaluations
- Pregnancy, planned pregnancy, or breastfeeding
- Previous chemotherapy, radiotherapy, or immunotherapy
- Severe coronary heart disease or heart failure (NYHA grade III/IV)
- Pulmonary fibrosis or severe lung dysfunction not suitable for surgery
- Autoimmune disease requiring systemic treatment within past 2 years
- Immunodeficiency or need for systemic steroid replacement therapy
- Motor or sensory neurotoxic diseases
- Mental illness
- Conditions affecting ability to receive planned treatment, such as drug allergies
- Acute infections needing systemic treatment
- Previous HIV, HBV, or HCV infections
- Prior stem cell or solid organ transplantation
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 - Duration varies by arm (2 or 4 cycles of chemoimmunotherapy, with or without radiotherapy) until surgery
Participants receive chemoimmunotherapy with carboplatin plus nab-paclitaxel and Pembrolizumab, with some also receiving radiotherapy, followed by surgery.
Multiple visits during chemotherapy cycles and radiotherapy sessions, plus surgery visit
Duration - Up to 5 years after therapy
Participants are monitored after surgery to assess recovery and long-term outcomes including survival and disease-free status.
Periodic visits for up to 5 years
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
Li Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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