RecruitingPhase 2Phase 3NCT04973306

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

Neoadjuvant Immunotherapy Combined With Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (cII-III Stage): A Multi-center Prospective Randomized Clinical Trial


Sponsor

Shanghai Zhongshan Hospital

Enrollment

176 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches before surgery for people with locally advanced squamous cell cancer of the oesophagus (food pipe): standard chemoradiation (chemotherapy plus radiation) versus chemoradiation combined with immunotherapy. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the thoracic (chest) oesophagus, confirmed by biopsy before any treatment - Your cancer is stage II or III (locally advanced but potentially operable) - You are between 18 and 75 years old - You are in good physical condition (ECOG 0–1) with expected survival over 12 months - You have adequate heart, lung, and bone marrow function **You may NOT be eligible if...** - Your cancer is of a different type (e.g., adenocarcinoma) or in a different location (e.g., cervical oesophagus) - Your cancer has spread to other organs (metastatic, stage IV) - Your heart, lung, or blood function is inadequate for treatment - You have an active autoimmune condition or are on immunosuppressive drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENeoadjuvant Chemoradiotherapy

Chemotherapy: carboplatin (AUC 2 mg/mL per min) and paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. For each cycle, Carboplatin and paclitaxel were administered 30 minutes apart. Radiotherapy: A total radiation dose of 41.4 Gy was given in 23 fractions of 1.8 Gy, 5 days per week (Radiotherapy was performed on the 2nd, 3rd, 4th, 5th, and 6th day in each cycle, and only 3 times in the 5th cycle)

DRUGTislelizumab

Tislelizumab (200mg/time) was administered intravenously on the 1st and 22nd day. The intravenous injection lasts about 30 minutes (micropump is recommended, intravenous bolus is prohibited, duration should be not less than 20 minutes and not more than 60 minutes);

PROCEDUREIvor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)

After neoadjuvant therapy, patients in groups receive Ivor-Lewis or Mckeown Esophagectomy (Mckeown Esophagectomy recommended)


Locations(1)

Shanghai Zhongshan Hospital

Shanghai, China

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NCT04973306