# ORIENT-32

Source: https://onco.cc/trials/orient-32/  
OnCo record `orient-32` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Chinese trial showing that a PD-1 antibody plus a bevacizumab copy extends life in liver cancer, mirroring the global IMbrave150 result in a hepatitis B population.

## Summary

571 patients randomised 2:1. Overall survival hazard ratio 0.57 (median not reached versus 10.4 months) and progression-free survival hazard ratio 0.56 at the first interim analysis; about 94% of patients had hepatitis B, the cause of most Chinese liver cancer. NMPA approval June 2021. With IMbrave150 it established anti-PD-(L)1 plus anti-VEGF as the first-line standard and gave China a reimbursed domestic option.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT03794440
- Phase: 2/3
- Setting: First-line unresectable hepatocellular carcinoma, China (mostly hepatitis B-related): sintilimab plus the bevacizumab biosimilar IBI305 vs sorafenib
- Sponsor: Innovent Biologics
- Enrolled: 595
- Result: OS HR 0.57; PFS HR 0.56.
- Outcomes: Overall survival: Sintilimab + IBI305 vs Sorafenib 10.4 months, HR 0.57

## Sources

- ClinicalTrials.gov NCT03794440: https://clinicaltrials.gov/study/NCT03794440
- Lancet Oncol 2021: https://doi.org/10.1016/S1470-2045(21)00252-7

## Connected records

- cancers: [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Sintilimab](https://onco.cc/drugs/sintilimab/), [Sorafenib](https://onco.cc/drugs/sorafenib/)
- companies: [Innovent Biologics](https://onco.cc/companies/innovent/)
- terms: [Hepatitis B and C as cancer causes](https://onco.cc/terms/hbv-hcv/)
- key papers: [Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study](https://onco.cc/key-papers/paper-ren-lancet-oncol/)

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