CClinicalTrials.gg
Not yet recruitingNCT06198465Updated Jan 10, 2024

Perioperative Adebrelimab and Chemotherapy in Esophageal and Esophagogastric Junction Carcinoma

A Phase 2 interventional study of adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil in Adebrelimab, Esophageal Cancer and Perioperative Period, sponsored by Xijing Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Xijing Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • Adebrelimab
  • Esophageal Cancer
  • Perioperative Period
03

In context

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    adebrelimab combined with chemotherapy

    Drug: adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil

Interventions

  • Drugadebrelimab,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;

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At time of surgery

Secondary outcomes

  1. R0 resection rate

    R0 resection rate

    Time frame: At time of surgery

  2. 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

    Time frame: up to 2 year

  3. Overall Survival (OS)

    defined as the time from randomization to death from any cause during the course of the study.

    Time frame: up to 2 year

  4. Number of participants with treatment-related adverse events

    assessed by CTCAE v4.03

    Time frame: 6 months

07

Study locations

1 site
  • The First Affiliated Hospital, the Air Force Medical University
    Xi'an, Shaanxi 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06198465
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Jan 10, 2024
Start date
Mar 30, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jan 10, 2024

Study contacts

Liu Hong, MD,PhD
Contact
hongliu180@126.com
13709284513

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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