Actively Recruiting
Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Led by Ning Jiang, M.D./Ph.D. · Updated on 2026-04-15
98
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
CONDITIONS
Official Title
Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent and agree to study requirements
- Aged 18 years or older and younger than 75 years
- Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma suitable for concurrent chemoradiotherapy, including stages II-IVa and select IVb cases
- Estimated life expectancy of at least 6 months
- ECOG performance status of 0 to 2
- Presence of measurable or non-measurable lesions per RECIST 1.1
- No prior systemic anti-tumor treatment
- Adequate organ function shown by laboratory tests within 14 days before enrollment, including specific blood counts, kidney function, liver enzymes, and bilirubin levels
- Controlled chronic or inactive HBV infection with HBV DNA less than 500 IU/mL during screening
- Female participants of childbearing potential agree to use effective contraception and have a negative pregnancy test before enrollment
- Male participants not sterilized agree to use effective contraception during the study and specified periods after treatment
You will not qualify if you...
- History of other malignancies
- History of fistula caused by tumor infiltration
- High risk or signs of esophageal fistula or perforation
- Previous esophageal cancer surgery
- Poor nutritional status with BMI below 18.5 kg/m² or PG-SGA score of 9 or higher
- Uncontrolled pleural effusion, pericardial effusion, or ascites needing repeated drainage within 2 weeks before randomization
- Known intolerance or resistance to the specified chemotherapy
- Prior anti-tumor therapies for esophageal squamous cell carcinoma
- Active or history of autoimmune diseases that may relapse
- Uncontrolled diabetes or certain laboratory abnormalities despite therapy
- History of interstitial lung disease or uncontrolled systemic diseases
- Severe infections requiring systemic treatment within 14 days before enrollment
- Known HIV infection
- Major surgery within 28 days before enrollment (excluding minor procedures)
- Prior stem cell or organ transplantation
- Recent cardiovascular events or uncontrolled cardiovascular conditions
- Severe allergic reactions to monoclonal antibodies or study chemotherapy drugs
- Recent use of chemotherapy, immunotherapy, investigational treatments, or herbal cancer medicines
- Unresolved toxicities from prior anti-tumor therapies
- Live vaccine received within 28 days prior to randomization
- Underlying diseases, substance abuse, or factors interfering with study participation
- Concurrent participation in another treatment trial
- Other investigator-assessed factors requiring study termination, such as involuntary detention or imprisonment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Cancer Hospital /Jiangsu Institute of Cancer Research
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
X
Xiangzhi Zhu
CONTACT
N
Ning Jiang
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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