RecruitingPhase 3NCT05043688

Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.

Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial


Sponsor

Zhigang Li

Enrollment

426 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding camrelizumab — an immunotherapy drug — to chemotherapy before surgery improves outcomes for patients with resectable (surgically removable) esophageal squamous cell carcinoma compared to chemoradiation alone. **You may be eligible if...** - You are between 18 and 75 years old with confirmed esophageal squamous cell cancer - Your cancer has not been previously treated - Your cancer is resectable (clinical stage T1b-T3 with lymph node involvement, or T3 without node involvement) - You are in good general health (ECOG 0–1) - Your major organ function is normal **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior treatment for esophageal cancer - You have active autoimmune disease requiring treatment - You have significant heart or lung disease - You are pregnant or breastfeeding - You have active hepatitis B or C, or HIV 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

DRUGCamrelizumab

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.

RADIATIONradiotherapy

The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.


Locations(5)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Anyang Tumour Hospital

Anyang, China

Sun yat-sen University Cancer Center

Guangzhou, China

Anhui Provincial Hospital

Hefei, China

Zhongshan Hospital of Fudan University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05043688


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