deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03748134

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

A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)

Sponsor: Fortrea

Conditions Esophageal Squamous Cell Carcinoma
Interventions Cisplatin Fluorouracil Paclitaxel Placebo Sintilimab
Updated 15 times since 2018 Last updated: Oct 22, 2023 Started: Dec 24, 2018 Primary completion: Sep 9, 2021 Completion: Jul 29, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Esophageal Squamous Cell Carcinoma and is currently completed. Fortrea leads this study, which shows 15 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Dec 2018 – ~Oct 2019 · 10 months · monthly snapshot~Oct 2019 – ~Apr 2020 · 6 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Sep 2022 · 9 months · monthly snapshot~Sep 2022 – ~Nov 2023 · 14 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Nov 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  5. Sep 2022 — Nov 2023 [monthly]

    Recruiting PHASE3

▶ Show 10 earlier versions

  1. Dec 2021 — Sep 2022 [monthly]

    Recruiting PHASE3

  2. Sep 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  3. Mar 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  4. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  5. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  6. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  7. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  8. Apr 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  9. Oct 2019 — Apr 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  10. Dec 2018 — Oct 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fortrea
  • Innovent Biologics (Suzhou) Co. Ltd.
Data source: Innovent Biologics (Suzhou) Co. Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anaheim, United States , Austin, United States , Barcelona, Spain , Beijing, China , Bettancourt-la-Ferrée, France , Bordeaux, France , Brussels, Belgium , Budapest, Hungary , Caen, France , Clermont-Ferrand, France and 32 more locations