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COMPLETED Phase 3

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

NCT03748134 · View on ClinicalTrials.gov ↗

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

Interventions

  • DRUG Placebo
  • DRUG Cisplatin
  • DRUG Fluorouracil
  • DRUG Paclitaxel
  • BIOLOGICAL Sintilimab

Study Locations (20)

Other

  • Institut Jules Bordet — Brussels
  • Centre Hospitalier Regional de Verviers — Verviers
  • Beijing Cancer Hospital — Beijing
  • Hôpital Jean Minjoz — Bettancourt-la-Ferrée
  • Institut Bergonié — Bordeaux

California

  • St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center — Anaheim
  • UC Irvine — Orange

Western Australia

  • Sir Charles Gairdner Hospital — Nedlands
  • St John of God Subiaco Hospital — Subiaco

Colorado

  • Rocky Mountain Cancer Centers, LLP — Denver

Georgia

  • IACT Health - John B. Amos Cancer center — Columbus

Oklahoma

  • Stephenson Cancer Center — Oklahoma City

Texas

  • Texas Oncology, P.A. — Austin

Washington

  • Northwest Cancer Specialists, P.C. — Vancouver

Trial Details

FieldValue
Enrollment Target 746 participants
Start Date 2018-12-24
Est. Completion 2023-07-29
Phase Phase 3

Sponsor

Innovent Biologics (Suzhou) Co.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03748134

The ClinicalTrials.gov registry entry for NCT03748134 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 746 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innovent Biologics (Suzhou) Co., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Esophageal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03748134 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, California, Western Australia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03748134 about?

NCT03748134 is a clinical study titled "Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )". 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 ...

What is the current status of trial NCT03748134?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 746 participants. The study started on 2018-12-24. Estimated completion is 2023-07-29.

What conditions does trial NCT03748134 study?

This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03748134?

The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Paclitaxel (DRUG), Sintilimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03748134?

This trial is sponsored by Innovent Biologics (Suzhou) Co., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03748134 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial