Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06663059

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

Led by Tang-Du Hospital · Updated on 2024-10-29

80

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.

CONDITIONS

Official Title

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and voluntary participation
  • Confirmed esophageal squamous cell carcinoma by histology or cytology
  • Locally advanced thoracic esophageal cancer staged as T1b-4aN+M0 or T2-4N0M0 with high-risk factors
  • Expected to achieve complete tumor removal (R0 resection)
  • Age between 18 and 75 years
  • ECOG Performance Status 0-1
  • No prior treatment for esophageal cancer
  • Plan to undergo surgery after neoadjuvant therapy
  • No contraindications for surgery
  • Normal major organ function based on hematology, biochemistry, and coagulation tests
  • Female participants of childbearing potential must have negative pregnancy test and use effective contraception
  • Male participants with fertile partners must use effective contraception
  • Good compliance and cooperation with follow-up
Not Eligible

You will not qualify if you...

  • Tumor invading adjacent organs like major arteries or trachea
  • Supraclavicular lymph node metastasis
  • Uncontrolled pleural, pericardial effusion or ascites needing repeated drainage
  • Poor nutritional status with BMI less than 18.5 kg/m² unless corrected and reassessed
  • Allergy to monoclonal antibodies, Adebrelimab, paclitaxel, cisplatin, or platinum drugs
  • Previous or current tumor-directed radiotherapy, chemotherapy, or anti-tumor drugs
  • Recent use of immunosuppressive drugs or systemic steroids over 10 mg/day prednisone equivalent within 2 weeks
  • Recent live attenuated vaccines within 4 weeks
  • Major surgery or severe trauma within 4 weeks
  • Active or history of autoimmune diseases requiring intervention
  • History of immunodeficiency or organ transplantation
  • Poorly controlled cardiac conditions or recent myocardial infarction
  • Severe infections within 4 weeks prior to study drug use
  • Active or recent pulmonary tuberculosis
  • Active hepatitis B or C infection
  • Other malignancies within 5 years except low-risk types
  • Pregnant or breastfeeding women
  • Any condition that may affect safety or compliance as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shannxi, China, 710038

Actively Recruiting

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Research Team

T

Tao Jiang, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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