Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma

Last updated: January 8, 2024
Sponsor: Xijing Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Esophageal Cancer

Treatment

adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil

Clinical Study ID

NCT06198465
XJEC
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 targetingtreatment 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 immunedeficiency 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;
  2. Platelet ≥ 100x10^9/L; 4) Serum creatinine ≤1.5 ULN or creatinine clearance rate≥50mL/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 patentmedicines, and immunomodulators (such as thymosin, interleukins, etc.) must be ≥ 2weeks from the start of study medication; 9. For females of child bearing potential, anegative serum/urine pregnancy test result within 72h before study treatment. Forfemale and male participants of reproductive potential must be willing to use adequatecontraception for the course of the study until 3 months after the last dose of any ofthe drugs in the study; 10.Volunteered to participate in the study, signed theinformed consent form; 11. Had good compliance and cooperated with the follow-up.

Exclusion

Exclusion Criteria:

  1. Suffering from any active autoimmune disease or history of autoimmune disease (such asinterstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) can beincluded after treatment); subjects with childhood asthma that has completely resolvedand do not require any intervention in adulthood or vitiligo can be included, butsubjects who require medical intervention with bronchodilators are not included;
  2. People with innate or acquired immune function defects, such as human immunodeficiencyvirus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C positivehepatitis C antibody, and high HCV-RNA (lower detection limit of the analyticalmethod) or combined with hepatitis B and hepatitis C co-infection; patients who haveused 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 tendencywithin 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 screeningperiod. If the gastroscopy results indicate severe gastric ulcer or the researcherdetermines 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 IIor 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 orantiviral drugs) within 4 weeks before the first dose, or unexplained fever >38.5°Cduring the screening period/before the first dose;
  8. Those who are known to have a history of allergies to the drug components of thisregimen;
  9. There may be increased risks of participation in research and study medication, orother severe, acute and chronic diseases;
  10. Other conditions deemed inappropriate for inclusion by the researcher.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil
Phase: 2
Study Start date:
March 30, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • The First Affiliated Hospital, the Air Force Medical University

    Xi'an, Shaanxi 710032
    China

    Site Not Available

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