Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT04973306

Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC

Led by Shanghai Zhongshan Hospital · Updated on 2022-06-30

176

Participants Needed

1

Research Sites

278 weeks

Total Duration

On this page

Sponsors

S

Shanghai Zhongshan Hospital

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study was to evaluate the safety, feasibility and outcome of anti-PD-1 antibody (Tislelizumab, BeiGene) combined with neoadjuvant chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy for locally advanced resectable esophageal squamous cell carcinoma (cII-III Stage) patient.

CONDITIONS

Official Title

Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically-confirmed esophageal squamous cell carcinoma with pre-treatment tissue samples
  • Tumors located in the thoracic esophagus
  • Clinical stage II or III esophageal cancer (AJCC/UICC 8th Edition)
  • Age between 18 and 75 years
  • ECOG performance status 0-1 and expected survival of at least 12 months
  • Adequate heart function (ECG normal; echocardiography if needed with left ventricular ejection fraction >50%)
  • Adequate lung function (FEV1 ≥1.2L, FEV1% ≥50%, DLCO ≥50%)
  • Adequate bone marrow function (WBC >4x10^9/L, neutrophils >2.0x10^9/L, hemoglobin >90 g/L, platelets >100x10^9/L)
  • Adequate liver function (total bilirubin <1.5x ULN, AST and ALT <1.5x ULN)
  • Adequate kidney function (glomerular filtration rate >60 ml/min, serum creatinine ≤120 µmol/L)
  • Provided written informed consent and able to comply with the study
Not Eligible

You will not qualify if you...

  • Non-squamous cell carcinoma histology
  • Advanced non-operable or metastatic esophageal cancer
  • Cancer stage cM+, cN3, cT4b (non-resectable), or early stages cTis-1a, cT1bN0
  • Other current or previous malignant diseases interfering with treatment or response assessment
  • Prior or ongoing chemotherapy, radiotherapy, targeted therapy, or immunotherapy
  • History of autoimmune diseases
  • Recent or current use of glucocorticoids or immunosuppressants
  • Allergy to antibody drugs, paclitaxel, or carboplatin
  • Chronic or recurrent autoimmune diseases
  • Active infection with HIV, hepatitis B or C viruses
  • History of organ transplantation
  • Severe systemic diseases such as uncontrolled infections, diabetes, coagulation disorders
  • Significant medical conditions affecting tolerance to therapy (heart, lung, bone marrow, liver, kidney diseases)
  • Pregnant or breastfeeding women and women not using contraception
  • Participation in other clinical trials interfering with this study within 30 days
  • Expected inability to comply with the protocol

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

Shanghai Zhongshan Hospital

Shanghai, China, 200032

Actively Recruiting

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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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