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NCT03748134 · ClinicalTrials.gov registry record · Phase 3
Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
A Phase 3 study of Esophageal Squamous Cell Carcinoma, sponsored by Innovent Biologics (Suzhou) Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 746
- Enrollment target
- 20
- Study locations
NCT03748134: Completed Phase 3 study of Esophageal Squamous Cell Carcinoma, sponsored by Innovent Biologics (Suzhou) Co..
NCT03748134 is a Phase 3 study of Esophageal Squamous Cell Carcinoma that has completed, run by Innovent Biologics (Suzhou) Co.. The registered enrollment target is 746 participants, above the 347-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03748134, a Phase 3 study of Esophageal Squamous Cell Carcinoma, has completed, sponsored by Innovent Biologics (Suzhou) Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 746 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
To compare the overall survival of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2018-12-24 |
| Est. Completion | 2023-07-29 |
| Phase | Phase 3 |
What the finished NCT03748134 record still lists
NCT03748134 is an interventional study that assigns participants to a tested intervention. The registered 746 participants enrollment target is mid-sized for trials with a published cap, above the 347-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (115% higher).
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.
NCT03748134 names 20 study sites across 14 states, led by Other, California, Western Australia.
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.
What interventions are being tested in trial NCT03748134?
The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Fluorouracil (DRUG), Paclitaxel (DRUG), Sintilimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03748134?
This trial is sponsored by Innovent Biologics (Suzhou) Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03748134's enrollment target sits among peer trials
746 4th of 22 higher than 19 of 22 other Esophageal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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