Actively Recruiting
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Peking Union Medical College Hospital · Updated on 2025-04-02
120
Participants Needed
1
Research Sites
259 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
Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
CONDITIONS
Official 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 by imaging
- Nodal status N0 or N+ without clear distant metastasis (M0) except cervical or supraclavicular lymph node metastasis (M1a)
- Tumor size longitudinal diameter 10 cm or less
- Tumor does not involve the dentate line
- ECOG performance status 0 or 1
- No hematological diseases, no liver or kidney dysfunction
- Absolute neutrophil count 1.5 x 10^9/L or higher
- Platelet count 100 x 10^9/L or higher
- Hemoglobin 11 g/L or higher
- ALT less than or equal to twice the upper normal limit
- Total bilirubin less than or equal to 1.5 times the upper normal limit
- Creatinine clearance rate 50 ml/min or higher
- Able to provide informed consent
You will not qualify if you...
- Tumor staging evaluated as T1 or T2
- Evidence of distant metastasis (M1) by PET/CT or other imaging
- Planned pregnancy or currently pregnant or breastfeeding
- History of prior chemotherapy, radiation therapy, or immunotherapy
- Severe coronary heart disease or heart failure (NYHA grade III/IV)
- Pulmonary interstitial fibrosis or severe pulmonary dysfunction preventing surgery
- Autoimmune disease requiring systemic treatment within past 2 years
- Immunodeficiency diseases 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 infectious diseases needing systemic treatment
- Previous HIV, HBV, or HCV infections
- History of stem cell or solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
Li Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here