Status:

COMPLETED

Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma

Lead Sponsor:

Anhui Provincial Hospital

Conditions:

Toxicity, Drug

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

Neoadjuvant chemoradiotherapy followed by surgery has been the standard modality for locally advance esophageal carcinoma. According to CROSS study, the pathological complete remission rate achieved b...

Detailed Description

Trial Title Neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab for initially inoperable patients with locally advanced esophageal squamous cell carcinoma: A Prospective, One-arm,...

Eligibility Criteria

Inclusion

  • 18-75 years old;
  • Eastern Cooperative Oncology Group (ECOG) 0-1;
  • Esophageal squamous cell carcinoma;
  • cT2-4aN0-3M0-1a (AJCC 8th) confirmed by radiological examination;
  • Initially inoperable at initial diagnosis confirmed by thoracic surgeons;
  • No esophageal hemorrhage and no esophageal fistula at initial diagnosis;
  • Treatment naive;
  • No contraindications for adjuvant chemoradiotherapy, camrelizumab and nimotuzumab;
  • Signature of inform consent.

Exclusion

  • younger than 18 years old or older than 75 years old;
  • ECOG\>1;
  • Esophageal adenocarcinoma, small-cell cancer and other pathological types;
  • Presence of esophageal hemorrhage and esophageal fistula at initial diagnosis;
  • Previous treatment of chemotherapy, radiotherapy, immune therapy and other treatment;
  • Contraindications for chemoradiotherapy, camrelizumab and nimotuzumab;
  • No signature of inform consent.

Key Trial Info

Start Date :

November 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2024

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT05355168

Start Date

November 1 2021

End Date

March 31 2024

Last Update

December 31 2024

Active Locations (1)

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1

Anhui Provicial Hospital

Hefei, Anhui, China