Actively Recruiting
Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-27
90
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC. The present study is a prospective, 3-arm, randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC. The study objectives include R0 resection rate, treatment-related adverse events, morbidity and mortality, 1-year progression-free survival (PFS), and 1-year overall survival (OS) rates. Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy. This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC.
CONDITIONS
Official Title
Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with esophageal squamous cell carcinoma confirmed by tissue examination
- Cancer located in the thoracic esophagus
- No previous cancer treatments like surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Locally advanced ESCC considered borderline unresectable or with extracapsular lymph node involvement
- Karnofsky Performance Scale score of 70 or higher
- Normal organ function including acceptable blood counts and liver and kidney function tests
You will not qualify if you...
- Having other primary cancers except cured basal cell skin cancer or cervical carcinoma in situ
- Any prior anti-cancer treatment before this study
- Advanced cancer with distant metastases including supraclavicular lymph nodes
- Major blood vessel involvement with high risk of bleeding
- High risk of esophageal perforation during treatment
- Active infections such as tuberculosis or hepatitis B or C
- Allergy to cancer treatment drugs including PD-1 inhibitors or chemotherapy
- Heart or lung problems preventing tolerance of treatment or surgery
- Pregnant or breastfeeding women or women without effective contraception
- Not meeting inclusion criteria as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China, 100021
Actively Recruiting
Research Team
X
Xin Wang, Doctor
CONTACT
Z
Ziyu Zheng, B.M
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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