Actively Recruiting
A Prospective, Single-arm, Exploratory Study of Adbelimumab Combined With Chemotherapy and Apatinib in Resectable Esophageal Squamous Cell Carcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-02
35
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Esophageal squamous cell carcinoma (ESCC) is a common and deadly digestive tract cancer with limited improvements in survival despite advances in surgery, radiotherapy, and chemotherapy. This trial focuses on patients with locally advanced, resectable ESCC, aiming to explore effective neoadjuvant treatments to reduce postoperative recurrence and improve survival. The study evaluates the safety and effectiveness of combining adbelimumab, chemotherapy, and apatinib before surgery for this condition. Participants will receive four cycles of preoperative neoadjuvant therapy with adbelimumab, albumin paclitaxel, carboplatin, and apatinib over 21-day cycles. Surgery, including minimally invasive esophagectomy techniques, will be performed 4 to 6 weeks after the last dose. Postoperative radiotherapy may be given based on the patient's clinical and pathological status. Adbelimumab treatment can continue for up to one year. Patients will be monitored throughout the study until disease progression, withdrawal, loss to follow-up, or death. During the study, researchers will collect blood and tumor samples before and after treatment to study immune changes. They will assess outcomes such as pathological complete response one month after surgery, major pathological response, objective response before surgery, and survival rates up to five years. Safety will be monitored by recording treatment-related adverse events and surgical outcomes. Overall, participants will be closely followed to evaluate the treatment's impact and safety over the study period.
CONDITIONS
Brief Title
Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age between 18 and 75 years
- Primary, resectable, histologically confirmed esophageal squamous cell carcinoma
- Clinical stage II to IVA according to AJCC TNM, 8th edition
- ECOG performance status 0 or 1
- No distant metastasis and resectable disease confirmed by thoracic oncologist
You will not qualify if you...
- Significant cardiovascular disease
- Current antiviral therapy or hepatitis B virus infection
- Pregnant or lactating female patients
- History of other malignancies within 5 years before screening
- Active or past autoimmune disease or immune deficiency
- Signs of distant metastases
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 - Approximately 12 weeks (4 cycles of 21 days each)
Participants receive preoperative neoadjuvant therapy consisting of Adbelimumab, Albumin paclitaxel, Carboplatin, and Apatinib for 4 cycles, with one cycle every 21 days.
4 visits (in-person) for each treatment cycle
Duration - 1 day for surgery plus immediate post-operative care
Participants undergo minimally invasive esophagectomy (IvorLewis or McKeown) including extensive lymphadenectomies, performed by experienced surgeons. Surgery occurs 4-6 weeks after the last treatment dose.
1 surgical procedure visit (in-person)
Duration - Up to 1 year or longer depending on participant status
Participants are monitored after surgery, including possible postoperative radiotherapy based on clinical and pathological findings. Adbelimumab may be maintained for up to 1 year. Follow-up continues until disease progression, withdrawal, loss of follow-up, or death.
Multiple visits for follow-up and treatment depending on clinical needs
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, China, 310009
Actively Recruiting
Research Team
M
Ming Wu, M.D
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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