Actively Recruiting
A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2022-05-11
130
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
CONDITIONS
Official Title
A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-80 years, male or female
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC)
- ESCC clinical stage T1b-2N+M0 or T3-4aN+/-M0 (8th edition AJCC/UICC TNM staging)
- Able to provide tumor tissue for PD-L1 expression testing
- Planned radical esophageal surgery with esophagogastric reconstruction and at least two-field lymph node dissection
- ECOG performance status 0 or 1
- Expected survival time of at least 12 weeks
- Body mass index (BMI) of at least 18.5 kg/m2 or pg-sga score A/B
- Adequate blood counts and organ function as specified (e.g., WBC ≥3.0×10⁹/L, hemoglobin ≥90 g/L, liver enzymes ≤2.5×ULN, creatinine clearance ≥60 mL/min)
- Normal or grade I heart function; lung function with FEV1 >1.2L and FEV1% >40%; Child-Pugh grade 5-6 liver function
- Negative pregnancy test for premenopausal women; contraception required for men and women of childbearing age during and 6 months after treatment
- Signed informed consent
- Willing and able to complete study procedures and follow-up
You will not qualify if you...
- Cervical esophageal squamous cell carcinoma
- Metastasis to cervical, supraclavicular, abdominal, retroperitoneal, or pelvic lymph nodes (except pericardial and left gastric nodes)
- Prior anti-tumor treatment for primary disease including surgery, chemotherapy, targeted therapy, immunotherapy, radiotherapy, or others within specified times
- Active or relapsed autoimmune or skin diseases requiring systemic treatment
- History of stem cell or organ transplantation
- Interstitial pneumonia, interstitial lung disease, or non-infectious pneumonia
- History of gastrointestinal perforation, fistula, abscess, bowel resection, or inflammatory bowel disease within 6 months
- Major surgery or trauma within 28 days
- Live vaccination within 28 days
- Use of corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days (with exceptions for short-term topical use)
- Infectious diseases requiring systemic treatment within 14 days
- Uncontrolled severe heart failure, angina, recent myocardial infarction, arrhythmia, hypertension, thromboembolism, recent stroke, uncontrolled diabetes or thyroid disease, or significant proteinuria
- Tuberculosis treated within 1 year
- HIV infection
- Active hepatitis B or C infection
- Pregnant or breastfeeding women
- Other cancers within 5 years except certain cured cancers
- Severe acute, chronic, or mental illness affecting study compliance
- Other investigator-assessed conditions unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
S
Song Zhao
CONTACT
Y
Yu Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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