Combining Adbelimumab with Chemotherapy and Apatinib for Esophageal Cancer Treatment
A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
This study is testing a new treatment that combines Adbelimumab with chemotherapy and Apatinib to see if it can help people with esophageal cancer live longer and reduce the chances of cancer coming back after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | adbelimumab, adbelizumab, apatinib, chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, China) |
| Trial ID | NCT06576973 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Adbelimumab, a PD-1/PD-L1 immunotherapy, in combination with chemotherapy and Apatinib for patients with resectable esophageal squamous cell carcinoma (ESCC). The study aims to provide a neoadjuvant treatment approach to reduce postoperative recurrence and improve survival rates in patients with locally advanced ESCC. Participants will receive a regimen that includes Adbelimumab, Albumin paclitaxel, and Carboplatin, followed by esophagectomy. The trial will assess the safety and efficacy of this combination therapy in a defined patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed, resectable esophageal squamous cell carcinoma at clinical stages II-IVA.
Not a fit: Patients with significant cardiovascular disease, distant metastasis, or a history of autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce recurrence in patients with esophageal squamous cell carcinoma.
How similar studies have performed: Other studies have shown promise in using PD-1/PD-L1 inhibitors in combination with chemotherapy for various cancers, suggesting potential success for this approach in ESCC.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent. 2. Patients age 18 to 75 years old. 3. Primary resectable, histologically confirmed esophageal squamous cell cancer. 4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition). 5. ECOG PS 0-1. 6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist. Exclusion Criteria: 1. With significant cardiovascular disease. 2. Current treatment with anti-viral therapy or HBV. 3. Female patients who are pregnant or lactating. 4. History of malignancy within 5 years prior to screening. 5. Active or history of autoimmune disease or immune deficiency. 6. Signs of distant metastases.
Where this trial is running
Hangzhou, China
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, China, China (Recruiting)
Study contacts
- Study coordinator: Ming Wu, M.D
- Email: iwuming22@zju.edu.cn
- Phone: +8613757118715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.