Actively Recruiting
Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC
Led by Shanghai Zhongshan Hospital · Updated on 2025-04-17
100
Participants Needed
5
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will explore the efficacy and safety of benmelstobart combined with radiochemotherapy compared to radiochemotherapy alone as neoadjuvant treatment for esophageal squamous cell carcinoma. It will also compare the effectiveness and safety of low-dose radiotherapy versus standard-dose radiotherapy in neoadjuvant regimens that include benmelstobart with concurrent radiochemotherapy. This research may provide more treatment options for patients with esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participate and sign informed consent with good compliance
- Aged 18 years and older, any gender
- ECOG performance status of 0 or 1
- Histologically confirmed clinical stages T1-3N+M0 or T3NanyM0 resectable esophageal squamous cell carcinoma
- No prior antitumor treatment for esophageal cancer including chemotherapy, hormone therapy, radiotherapy, or immunotherapy
- Laboratory tests within 7 days prior to enrollment meeting specified blood counts, liver, kidney, coagulation, thyroid function, and heart function criteria
- Female participants must use contraception during the study and for 6 months after, have a negative pregnancy test within 7 days prior to enrollment, and not be breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Presence of other malignant tumors except previously cured basal cell carcinoma of the skin
- Diagnosis of cervical esophageal cancer
- Severe hypersensitivity to monoclonal antibodies
- Active or history of autoimmune diseases except certain controlled conditions like vitiligo, psoriasis, alopecia, well-controlled type 1 diabetes, and treated hypothyroidism
- Use of immunosuppressants or systemic hormone therapy within 2 weeks prior to first dose
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Uncontrolled neurological symptoms from brain metastases or evidence of brain/leptomeningeal disease
- Severe or uncontrolled diseases including certain heart conditions and infections
- Vaccination with preventive or attenuated vaccines within 4 weeks prior to first dose
- Factors that could lead to early study termination as judged by investigator
- Positive hepatitis B or C tests with uncontrolled viral load or not under effective treatment
- Positive HIV test
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041
Actively Recruiting
2
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110041
Actively Recruiting
3
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300202
Actively Recruiting
5
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
L
Lijie Tan, Professor
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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