Actively Recruiting
Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC
Led by Zhejiang Cancer Hospital · Updated on 2022-08-19
100
Participants Needed
3
Research Sites
243 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Cancer Hospital
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To observe the 1-year disease-free survival rate （1-year PFS） of patients with resectable esophageal squamous cell carcinoma who received neoadjuvant chemoradiotherapy combined with camrelizumab and achieved clinical complete remission with watchful waiting strategy.
CONDITIONS
Official Title
Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any study procedures
- Eastern Collaboration Group (ECOG) physical status score 0-1
- Histologically confirmed thoracic esophageal squamous cell carcinoma at clinical stage cT2-4aNanyM0 or cT1-3N+M0
- Presence of measurable lesions according to RECIST criteria
- Available tumor tissue samples for PD-L1 immunohistochemistry testing
- No major pathological conditions increasing surgical risk such as esophageal perforation, active bleeding, or invasion of trachea or large thoracic blood vessels
- Adequate lung function to tolerate esophageal cancer resection according to surgeon's assessment
- Age between 18 and 75 years
- Females of childbearing potential must have a negative pregnancy test within 24 hours prior to treatment
- Women must not be nursing
You will not qualify if you...
- Locally advanced unresectable or metastatic esophageal cancer
- Grade 2 or higher peripheral neuropathy
- Active, known, or suspected autoimmune disease (except certain stable skin disorders and hormone replacement thyroid disease)
- Need for systemic glucocorticoids (>10 mg prednisone daily) or other immunosuppressive drugs within 14 days before treatment
- Positive HIV test or AIDS diagnosis
- Serious or uncontrolled medical illness
- Prior chest radiotherapy, chemotherapy, immunotherapy, or surgery for esophageal or gastric cancer
- Severe cardiovascular or pulmonary disease, interstitial pneumonia, or history of interstitial pneumonia
- Obvious esophageal ulcers, moderate chest and back pain, or esophageal perforation symptoms
- Laboratory abnormalities including low white blood cell, neutrophil, platelet counts, or hemoglobin
- Abnormal kidney or liver function tests exceeding specified limits
- Active hepatitis B or C infection
- Active malignancy within the past 3 years except certain curable cancers
- History of allergic reactions or hypersensitivity to study drug components
- Inability to understand or comply with trial requirements
- Active infection requiring systemic therapy within 14 days before first dose
- Other diseases deemed exclusionary by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hanzhou, Zhejiang, China
Not Yet Recruiting
2
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
Actively Recruiting
3
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Not Yet Recruiting
Research Team
Q
Qixun Chen
CONTACT
Y
Yongling Ji
CONTACT
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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