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Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )

NCT03748134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2023-10-24

No results posted yet for this study

Summary

This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma

Conditions

Interventions

BIOLOGICAL

Sintilimab

For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1

DRUG

Cisplatin

75mg/m\^2 IV Q3W day 1

DRUG

Paclitaxel

87.5 mg/m\^2 IV Q3W day 1, day 8 for first cycle and 175mg/m\^2 IV Q3W day 1 after first cycle

DRUG

Fluorouracil

800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W

DRUG

Placebo

For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-24
Primary Completion
2021-09-09
Completion
2023-07-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • France
  • Hungary
  • Spain

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 NCT03748134 on ClinicalTrials.gov