Actively Recruiting
A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.
Led by Fudan University · Updated on 2023-07-25
100
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, prospective, phase II trial for patients with metastatic esophageal squamous cell carcinoma (ESCC) who received immunotherapy plus chemotherapy as the first-line treatment. The aim of the study is to determine if intervening with combined local therapy and immunotherapy and chemotherapy in patients with ESCC led to significant improvements in survival and disease control compared with historical data.
CONDITIONS
Official Title
A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years with an Eastern Cooperative Oncology Group performance status of 0-1
- Diagnosed with unresectable, recurrent, or metastatic esophageal squamous cell carcinoma
- No prior systemic therapy, except progression occurred 6 months or more after previous neoadjuvant or chemoradiation therapy
- Received at least one cycle of anti-PD-1 immunotherapy combined with chemotherapy as first-line treatment
- No local treatment (radiotherapy, surgery, or radiofrequency ablation) to current lesions before enrollment
- Measurable lesions per RECIST 1.1 assessment as determined by the investigator
- Estimated survival time greater than 12 weeks
- Adequate vital organ function including specified blood counts, liver and kidney function, and lung function if applicable
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours prior to enrollment and agree to contraception
- Voluntary informed consent provided by patient or legal representative
You will not qualify if you...
- Prior exposure to immune-mediated therapy
- Participation in any investigational drug study within 4 weeks before starting treatment
- Unresolved toxicity from previous anti-tumor treatment above CTCAE v5.0 level 1, except hair loss
- Uncontrolled brain metastases or vertebral metastases causing spinal cord compression symptoms
- Uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage
- History of immunodeficiency or severe uncontrolled medical diseases affecting treatment
- Diagnosis of any other malignant tumor within 5 years before or after ESCC diagnosis, except low-risk tumors such as well-treated basal cell or squamous cell skin cancer or cervical cancer in situ
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai cancer center
Shanghai, China
Actively Recruiting
Research Team
Q
Qi Liu, M.D.
CONTACT
K
Kuaile Zhao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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