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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and feasibility of preserving organs using camrelizumab combined with chemotherapy in patients diagnosed with resectable esophageal squamous carcinoma. This multicenter phase II clinical trial focuses on patients confirmed to have esophageal squamous carcinoma that can be surgically removed. The goal is to explore treatment options that may improve outcomes and organ preservation in this patient group. Participants will receive three cycles of neoadjuvant therapy including camrelizumab (200 mg per dose intravenously every 3 weeks), nab-paclitaxel (260 mg/m2 intravenously every 3 weeks), and cisplatin (75 mg/m2 intravenously every 3 weeks). Patients opting for organ preservation may enter a watchful waiting group receiving radiotherapy (50.4 Gy in 28 doses) followed by camrelizumab maintenance therapy for 4 to 12 weeks after radiotherapy, with a total treatment duration of up to one year of camrelizumab. Throughout the study, participants will undergo evaluations including tumor measurements and organ function tests to assess treatment response and safety. Researchers will monitor outcomes such as event-free survival over about two years, clinical and pathological remission rates, progression-free survival, overall survival in organ preservation cases, and adverse events. Participants will be followed closely during treatment and for approximately two years to gather comprehensive data on treatment effects and safety.
CONDITIONS
Brief 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...
- Subjects must voluntarily enroll, sign informed consent, comply with study procedures, and be able to attend follow-up visits
- Histopathologically confirmed esophageal cancer with clinical staging cT1b-cT2 N+ M0 or cT3, any N, M0 (AJCC 8th edition)
- Age between 18 and 75 years, male or female
- ECOG performance status of 0 or 1
- Measurable tumor lesions or evaluable non-measurable lesions
- No prior anti-tumor treatment for esophageal cancer
- Lung function adequate for surgery (VC% >60%, FEV1 >1.2L, FEV1% >40%, DLco >40%)
- No contraindications to surgery
- Adequate vital organ function as specified, including normal bone marrow, renal, liver, and coagulation parameters
- Use of medically approved contraception during and for 6 months after treatment for patients of childbearing potential; negative pregnancy test and not breastfeeding
You will not qualify if you...
- Locally advanced unresectable or metastatic esophageal cancer (stage IV)
- Cervical segment esophageal cancer
- Allergy to monoclonal antibodies or components of study drugs (camrelizumab, nab-paclitaxel, platinum drugs)
- Moderate or severe chest/back pain with risk of esophageal perforation
- Prior radiotherapy, chemotherapy, or immunosuppressive treatment as specified
- Active autoimmune disease or history of autoimmune diseases requiring intervention
- History of immunodeficiency, HIV, organ or bone marrow transplantation
- Uncontrolled cardiac conditions including certain heart failures, unstable angina, recent myocardial infarction, or serious arrhythmias
- Recent serious infections or active infectious diseases including tuberculosis and hepatitis B or C with specified viral loads
- Other malignancies within 5 years except low-risk treated cancers
- Pregnant or lactating females
- Other medical or social conditions that may affect study safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive three cycles of neoadjuvant therapy with camrelizumab combined with chemotherapy, followed by radiotherapy and maintenance camrelizumab therapy for up to one year for those in the organ preservation group.
Visits every 3 weeks during chemotherapy cycles and additional visits during radiotherapy and maintenance therapy
Duration - About 2 years
Participants are monitored for clinical outcomes including survival and adverse events for up to about 2 years after treatment.
Periodic follow-up visits during the monitoring period
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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