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Trial Title:
Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06576973
Condition:
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Carboplatin
Apatinib
Conditions: Keywords:
Adbelimumab
Chemotherapy
Apatinib
Esophageal Squamous Cell Carcinoma
Neoadjuvant Treatment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adbelimumab, Albumin paclitaxel, Carboplatin, Apatinib
Description:
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.
Arm group label:
Adbelimumab, chemotherapy and apatinib
Other name:
Esophagectomy
Intervention type:
Procedure
Intervention name:
Esophagectomy
Description:
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.
Arm group label:
Adbelimumab, chemotherapy and apatinib
Intervention type:
Other
Intervention name:
Collecting samples from participant
Description:
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.
Arm group label:
Adbelimumab, chemotherapy and apatinib
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Wu, M.D
Phone:
+8613757118715
Email:
iwuming22@zju.edu.cn
Start date:
August 8, 2024
Completion date:
December 2031
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06576973
