# ORIENT-16

Source: https://onco.cc/trials/orient-16/  
OnCo record `orient-16` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The Chinese stomach cancer trial that showed adding sintilimab to chemotherapy helps patients live longer, especially when the tumour expresses PD-L1.

## Summary

650 patients. Median overall survival 15.2 versus 12.3 months in all randomised patients (hazard ratio 0.77) and 18.4 versus 12.9 months in the PD-L1 CPS 5 or higher group (hazard ratio 0.66), published in JAMA in 2023. NMPA approval 2023. With CheckMate 649, KEYNOTE-859 and RATIONALE-305 it makes gastric cancer the disease where Chinese PD-1 trials most changed global practice.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT03745170
- Phase: 3
- Setting: First-line unresectable gastric or gastro-oesophageal junction adenocarcinoma, China: sintilimab or placebo plus oxaliplatin and capecitabine
- Sponsor: Innovent Biologics
- Enrolled: 650
- Result: OS 15.2 vs 12.3 months (HR 0.77); CPS ≥5: 18.4 vs 12.9 months (HR 0.66).
- Outcomes: Overall survival, all randomised: Sintilimab + CAPOX 15.2 months vs Placebo + CAPOX 12.3 months, HR 0.77

## Sources

- ClinicalTrials.gov NCT03745170: https://clinicaltrials.gov/study/NCT03745170
- JAMA 2023: https://doi.org/10.1001/jama.2023.19918

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/), [Sintilimab](https://onco.cc/drugs/sintilimab/)
- companies: [Innovent Biologics](https://onco.cc/companies/innovent/)
- terms: [Combined positive score (CPS)](https://onco.cc/terms/cps/)
- people: [Jianming Xu](https://onco.cc/people/xu-jianming/)
- key papers: [Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial](https://onco.cc/key-papers/paper-xu-jama/)

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