Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

NCT ID: NCT06576973

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2031-12-31

Brief Summary

Esophageal cancer is a prevalent digestive tract tumor, with around 400,000 new cases and 300,000 deaths globally each year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma (ESCC) patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate.

Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect.

The results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles, with no adverse reactions of grade 3 or higher. The trial reported a major pathological response (MPR) rate of 24%, a pathological complete response (pCR) rate of 8%, a 2-year overall survival (OS) rate of 92%, and a 2-year recurrence-free survival (RFS) rate of 100%. The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain.

This study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable ESCC.

Conditions

Esophageal Squamous Cell Carcinoma; Neoadjuvant Treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adbelimumab, chemotherapy and apatinib

Preoperative neoadjuvant therapy for 4 cycles. Radical surgery is performed 4-6 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Adbelimumab can be aintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.

Group Type: EXPERIMENTAL

Adbelimumab, Albumin paclitaxel, Carboplatin, Apatinib

Intervention Type: DRUG

Adbelimumab 1200mg Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Apatinib 250mg Po Day 2-4. Preoperative neoadjuvant therapy for 4 cycles, one cycle every 21 days.

Esophagectomy

Intervention Type: PROCEDURE

Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive IvorLewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy. The surgeries will be performed by surgeons with rich experience. Minimally invasive esophagectomy, can be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or by using an open approach, as judged appropriate by the surgeon.

Collecting samples from participant

Intervention Type: OTHER

Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use. 20 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery. Tumour sample will be collected before neoadjuvant therapy and after surgery.

Interventions

Adbelimumab, Albumin paclitaxel, Carboplatin, Apatinib

Adbelimumab 1200mg Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Apatinib 250mg Po Day 2-4. Preoperative neoadjuvant therapy for 4 cycles, one cycle every 21 days.

Intervention Type: DRUG

Esophagectomy

Prior to each surgical procedure, the department engaged in comprehensive discussions and deliberations to ascertain and establish the most suitable course of action. Minimally invasive IvorLewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two field extensive lymphadenectomies, was performed according to the tumor location. The resection length should be at least 5cm from the tumor origin according to prechemotherapy by endoscopy. The surgeries will be performed by surgeons with rich experience. Minimally invasive esophagectomy, can be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or by using an open approach, as judged appropriate by the surgeon.

Intervention Type: PROCEDURE

Collecting samples from participant

Blood, Tumour will be Collected from participant. Fate of sample is Destruction after use. 20 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery. Tumour sample will be collected before neoadjuvant therapy and after surgery.

Intervention Type: OTHER

Other Intervention Names

Esophagectomy

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Wu, M.D

Role: CONTACT

iwuming22@zju.edu.cn

+8613757118715

Facility Contacts

Ming Wu, M.D

Role: primary

iwuming22@zju.edu.cn

+8613757118715

Other Identifiers

2024-0949

Identifier Type: -

Identifier Source: org_study_id