NCT03748134

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

Completed Phase 3 Last updated 24 October 2023

What this trial tests

Phase 3 trial testing Sintilimab in Esophageal Squamous Cell Carcinoma in 746 participants. Completed in 29 July 2023.

Timeline

24 December 2018

Primary endpoint
9 September 2021

29 July 2023

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	746
Start date	24 December 2018
Primary completion	9 September 2021
Estimated completion	29 July 2023
Sites	48 locations across France, Belgium, Hungary, Australia, China, United States, Spain

Drugs / interventions tested

• Sintilimab
• Cisplatin (cisplatin) — full drug profile →
• Paclitaxel — full drug profile →
• Fluorouracil — full drug profile →
• Placebo

Conditions studied

• Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial.
   Lu Z, Wang J, Shu Y, Liu L, et al · · 2022 · cited 322× · PMID 35440464 · DOI 10.1136/bmj-2021-068714
2. Sintilimab: A Promising Anti-Tumor PD-1 Antibody.
   Zhang L, Mai W, Jiang W, Geng Q. · · 2020 · cited 109× · PMID 33324564 · DOI 10.3389/fonc.2020.594558
3. Can Cisplatin Therapy Be Improved? Pathways That Can Be Targeted.
   Ali R, Aouida M, Alhaj Sulaiman A, Madhusudan S, et al · · 2022 · cited 51× · PMID 35806243 · DOI 10.3390/ijms23137241
4. Neoadjuvant sintilimab and chemotherapy in patients with resectable esophageal squamous cell carcinoma: A prospective, single-arm, phase 2 trial.
   Zhang Z, Ye J, Li H, Gu D, et al · · 2022 · cited 37× · PMID 36311804 · DOI 10.3389/fimmu.2022.1031171
5. The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer.
   Yang H, Wang K, Wang T, Li M, et al · · 2020 · cited 35× · PMID 32195194 · DOI 10.3389/fonc.2020.00300
6. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
7. Immune evasion in esophageal squamous cell cancer: From the perspective of tumor microenvironment.
   Li R, Huang B, Tian H, Sun Z. · · 2022 · cited 33× · PMID 36698392 · DOI 10.3389/fonc.2022.1096717
8. Current status and perspectives of esophageal cancer: a comprehensive review.
   Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645