CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 426 target
Drug / intervention
Camrelizumab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 10
  • Pathologically confirmed esophageal squamous cell carcinoma
  • No prior systemic or local treatment for esophageal cancer
  • Age 18-75 years
  • ECOG performance status 0-1
Key exclusion· 21
  • Unresectable tumors or unresectable surgical contraindications
  • Supraclavicular lymph node metastasis
  • Poor nutritional status, BMI <18.5 kg/m²
  • Known allergy to study drug components

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05043688
NCT05043688Phase 3RecruitingOn TrackUpdated 20mo ago
Long Recruiting

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

Zhigang Li·interventional·Posted Sep 14, 2021·Updated Oct 17, 2024

In Brief

A Phase 3 clinical trial evaluating Camrelizumab and radiotherapy for Resectable Esophageal Squamous Cell Carcinoma. Currently recruiting, targeting 426 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 3Recruiting
2022202320242025202620272028202920302031
First PostedSep 14, 2021
Enrollment StartSep 1, 2021
Primary CompletionDec 31, 2028
Study CompletionDec 31, 2030
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 4.8 years agoPrimary completion in 2.5 years

Interventions

Camrelizumabdrug

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.

radiotherapyradiation

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.