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Sintilimab Injection Combined With Concurrent CCRT in Locally Advanced Esophageal Squamous Cell Carcinoma

NCT04602013 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-10-26

No results posted yet for this study

Summary

This study evaluated the effectiveness and safety of sintilimab combined with cCRT in patients with locally advanced ESCC.

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Sintilimab

Body weight \<60kg: 3mg/kg IV Q3W; Body weight ≥60kg: 200mg IV Q3W. Every three weeks is a cycle

DRUG

Chemotherapy

Chemotherapy drugs include cisplatin and albumin-bound paclitaxel for injection Paclitaxel for injection (albumin-bound type) dose: 3 dose groups (di=260 mg/m2, di-1=220 mg/m2, di-2=180 mg/m2). Dosing on the first day, one cycle every three weeks, a total of 2 cycles. Cisplatin (25mg/m2 IV D1-3 Q3W)

RADIATION

Radiation Therapy

The total dose is 60-66 Gy, divided into 30-33 times (2.0 Gy/f, 5 f per week).

Sponsors & Collaborators

  • General Hospital of Ningxia Medical University

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Affiliated Hospital of Southwest Medical University

    collaborator OTHER

  • Chongqing Three Gorges Central Hospital

    collaborator OTHER

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Tao Li · Sichuan Cancer Hospital and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04602013 on ClinicalTrials.gov