Actively Recruiting
A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer
Led by Peking University Cancer Hospital & Institute · Updated on 2025-10-02
283
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma.
CONDITIONS
Official Title
A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled and signed informed consent with ability to comply and follow up
- Histologically confirmed esophageal cancer with clinical stage cT1b-cT2 N+ M0 or cT3 any N M0 (AJCC 8th edition)
- Age between 18 and 75 years, any gender
- ECOG performance status 0 or 1
- Measurable or evaluable tumor lesions
- No previous anti-tumor therapy for esophageal cancer including surgery, chemotherapy, or radiotherapy
- Lung function sufficient for surgery (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco > 40%)
- No contraindications to surgery
- Adequate vital organ function meeting specified blood counts, renal, liver, and coagulation parameters
- Use of medically approved contraception during and for 6 months after treatment if of childbearing potential; negative pregnancy test before enrollment; not breastfeeding
You will not qualify if you...
- Locally advanced unresectable or metastatic esophageal cancer
- Cervical segment esophageal cancer
- Allergy to monoclonal antibodies, camrelizumab components, albumin-bound paclitaxel, carboplatin, or other platinum drugs
- Moderate or greater chest/back pain with risk of esophageal perforation
- Prior treatment with radiotherapy, chemotherapy, immunosuppressants, systemic hormonal immunosuppression (above specified doses), live attenuated vaccines within 4 weeks, major surgery or severe trauma within 4 weeks
- Active autoimmune diseases or history of autoimmune disease except stable psoriasis or childhood asthma/allergies without intervention needed
- History of immunodeficiency, including HIV or organ/bone marrow transplantation
- Uncontrolled cardiac conditions including NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Serious infection requiring hospitalization or active infectious comorbidities within 4 weeks
- Active tuberculosis infection or recent history without regular treatment
- Active hepatitis B or hepatitis C infection above specified viral load thresholds
- Other malignancies diagnosed within 5 years except certain low-risk cancers
- Pregnancy or lactation
- Other serious illnesses or conditions that may affect safety or compliance as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, China, 100142
Actively Recruiting
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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