Actively Recruiting
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Led by Fujian Medical University Union Hospital · Updated on 2024-09-19
48
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University Union Hospital
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
CONDITIONS
Official Title
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years, male or female
- No prior systemic or localized treatment for esophageal squamous cell carcinoma
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (clinical stage II-IVA, or stage IVB with supraclavicular lymph node metastasis only)
- No surgical resection planned or refusal of surgical resection
- ECOG performance status score of 0-1
- Life expectancy of at least 3 months
- Adequate organ function
- Fertile men and women agree to use contraception during the study and for six months after last study drug
- Voluntary enrollment with signed informed consent and willingness to comply with study visits
You will not qualify if you...
- Low body weight (BMI less than 18.5 kg/m2) or 10% or more weight loss in past 2 months
- Esophageal lesions with major invasion to nearby organs or deep large ulcers with bleeding or fistula risk, or prior esophageal perforation/fistula within 6 months
- Prior immunotherapy treatment
- Participation in another clinical trial or use of investigational drugs within 4 weeks before study drug
- Planned or recent prophylactic or live vaccines within 4 weeks before study drug
- Corticosteroid therapy within 2 weeks before study drug
- Previous tissue/organ transplant or allogeneic stem cell transplant
- Active or suspected autoimmune disease
- Uncontrolled heart disease or symptoms
- Active or uncontrolled serious infections (grade 2 or higher)
- Active tuberculosis or history within 12 months
- History of interstitial lung disease or non-infectious pneumonia
- Active hepatitis B or C infection, positive HIV or AIDS
- Other malignancies within past 5 years except certain skin or early prostate cancers
- Known allergies to study drugs or ingredients
- Other serious physical or mental illnesses or abnormal labs increasing risk or interfering with study or deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Y
Yong Yang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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