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Sintilimab Plus NCT or NCRT Versus NCRT for ESCC

NCT05244798 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2022-10-25

No results posted yet for this study

Summary

Comparative analysis of patients with resectable locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy combined sintilimab versus neoadjuvant chemoradiotherapy.

Conditions

Interventions

DRUG

Sintilimab

Sintilimab: D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W)

RADIATION

radiotherapy

Radiotherapy: According to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week.

DRUG

Chemotherapy

Neoadjuvant chemotherapy with TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W).

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Anyang Tumor Hospital

    collaborator OTHER

  • Shantou Central Hospital

    collaborator OTHER

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • GeneCast Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244798 on ClinicalTrials.gov