Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma

Esophageal Cancer Clinical Trial

Official title:

Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma: a Prospective, Open-label, Single-center Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06198465
• Other study ID #: XJEC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 30, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: Xijing Hospital
• Contact: Liu Hong, MD,PhD
• Phone: 13709284513
• Email: hongliu180[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this prospective, open-label, single-center clinical study is to learn about the efficacy and safety of aderbelimab combined with chemotherapy in the perioperative treatment of esophageal and esophagogastric junction cancer. The main question it aims to answer are:prediction for pCR after perioperative adebrelimab and chemotherapy in esophageal and esophagogastric junction carcinoma

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged =18 years, both genders;

2. Histologically or cytological confirmed esophageal and esophagogastric junction cancer (cT3-4, anyN, M0);

3. Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for esophageal and esophagogastric junction cancer;

4. According to the RECIST v1.1 standard, there must be at least 1 measurable lesion;

5. ECOG PS score 0-1;

6. Adequate organ function, and there are no serious functional abnormalities or immune deficiency diseases such as blood, heart, lung, liver, kidney, bone marrow, etc. Laboratory examinations meet the following requirements:

1) Hemoglobin = 90 g/L; 2) Leukocytes = 3.0x10^9/L; Absolute neutrophil count= 1.5x10^9/L; 3) Platelet = 100x10^9/L; 4) Serum creatinine =1.5 ULN or creatinine clearance rate=50 mL/min; 5) Total bilirubin =1.5 ULN; 6) ALT =2.5 ULN; AST =2.5 ULN; 7) Urinary protein <2+; if urine protein=2+, 24-hour urine protein quantification shows that the protein must be =1g; 7. Coagulation function test:

1. INR =1.5 ULN;

2. APTT =1.5 ULN;

3. PT=1.5ULN; 8.Previous use of anti-tumor traditional Chinese medicines, Chinese patent medicines, and immunomodulators (such as thymosin, interleukins, etc.) must be = 2 weeks from the start of study medication; 9. For females of child bearing potential, a negative serum/urine pregnancy test result within 72h before study treatment. For female and male participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study; 10.Volunteered to participate in the study, signed the informed consent form; 11. Had good compliance and cooperated with the follow-up.

Exclusion Criteria:

1. Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) can be included after treatment); subjects with childhood asthma that has completely resolved and do not require any intervention in adulthood or vitiligo can be included, but subjects who require medical intervention with bronchodilators are not included;

2. People with innate or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C positive hepatitis C antibody, and high HCV-RNA (lower detection limit of the analytical method) or combined with hepatitis B and hepatitis C co-infection; patients who have used other drugs for clinical trial research within 4 weeks before the first dose;

3. Have had clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months;

4. Such as gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcer, or vasculitis; a gastroscopy is required during the screening period. If the gastroscopy results indicate severe gastric ulcer or the researcher determines that there is bleeding, If the risk is high, you will not be eligible; gastrointestinal perforation or gastrointestinal fistula has occurred within 6 months;

5. Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II or above heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia;

6. The number of neutrophils in peripheral blood <1500/mm3;

7. Severe infection (e.g. requiring intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose, or unexplained fever >38.5°C during the screening period/before the first dose;

8. Those who are known to have a history of allergies to the drug components of this regimen;

9. There may be increased risks of participation in research and study medication, or other severe, acute and chronic diseases;

10. Other conditions deemed inappropriate for inclusion by the researcher.

Related Conditions & MeSH terms

• Esophageal Cancer
• Perioperative Period

Intervention

Drug:
• adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil
adebrelimab: 1200mg,D1,q3w; Paclitaxel: 50mg/m2 D1/8/15; Lobaplatin: 50mg,iv 2h,d1; Fluorouracil: 400mg/m2,bolus iv,600mg/m2,iv 22h,d1-3;

Locations

Country	Name	City	State
China	The First Affiliated Hospital, the Air Force Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (pCR)	defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory	At time of surgery
Secondary	R0 resection rate	R0 resection rate	At time of surgery
Secondary	Disease-Free Survival (DFS)	Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death	up to 2 year
Secondary	Overall Survival (OS)	defined as the time from randomization to death from any cause during the course of the study.	up to 2 year
Secondary	Number of participants with treatment-related adverse events	assessed by CTCAE v4.03	6 months