# Xia 2004: the randomised trial behind China's approval of the oncolytic adenovirus H101

Source: https://onco.cc/key-papers/paper-xia-h101-head-neck-aizheng-2004/  
OnCo record `paper-xia-h101-head-neck-aizheng-2004` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding injections of an engineered adenovirus to chemotherapy roughly doubled the proportion of head and neck or oesophageal cancers that shrank, but the trial reported no survival figures.

## Summary

Phase 3 randomised trial of intratumoural H101, an E1B-55 kilodalton gene-deleted replication-selective adenovirus of essentially the same design as ONYX-015, added to cisplatin-based chemotherapy in squamous cell cancer of the head and neck or oesophagus. 160 patients were recruited. Patients with no history of, or sensitivity to, cisplatin and fluorouracil received that regimen; those who had not responded to it received doxorubicin and fluorouracil. Each group was randomised to receive intratumoural H101, at 5.0 x 10^11 to 1.5 x 10^12 viral particles per day for five consecutive days every three weeks, or not.

Among 123 evaluable patients, overall response rate with cisplatin and fluorouracil plus H101 was 78.8 per cent (41 of 52) against 39.6 per cent (21 of 53) for that chemotherapy alone. The differences between the combined virus arms and the chemotherapy-alone arms were significant. The main side effects were fever in 45.7 per cent, injection-site reaction in 28.3 per cent and influenza-like symptoms in 9.8 per cent. H101 was approved in China in 2005 and marketed as Oncorine, making it the first oncolytic virus approved anywhere.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Journal: Ai Zheng (Chinese Journal of Cancer)
- Year: 2004
- Authors: Xia ZJ, Chang JH, Zhang L, et al.
- Findings: Overall response rate 78.8 per cent (41 of 52) with cisplatin, fluorouracil and H101 versus 39.6 per cent (21 of 53) with cisplatin and fluorouracil alone (p = 0.000 as reported).; In the doxorubicin and fluorouracil groups, response was 50.0 per cent (7 of 14) with H101 and 50.0 per cent (2 of 4) without, on numbers too small to compare.; Commonest side effects were fever (45.7 per cent), injection-site reaction (28.3 per cent) and influenza-like symptoms (9.8 per cent).; The report gives response rates only; no overall or progression-free survival result is presented.
- What it means: The world's first approval of an oncolytic virus rests on a response-rate trial of 160 patients with no survival endpoint, an uneven randomisation across two chemotherapy backbones, and 37 patients excluded from the efficacy analysis. Tumour shrinkage after injecting something into a tumour is the easiest result to obtain in this field and the least informative. H101 has never been approved outside China.
- Caveats: No survival data. Response rate in an open-label trial with injected lesions is a weak endpoint.; 123 of 160 recruited patients were analysed, without a described intention-to-treat analysis.; The doxorubicin and fluorouracil comparison has four patients in the control arm.; Published in Chinese in a national journal, with no DOI, and never replicated in a registrational trial outside China.

## Sources

- PubMed: https://pubmed.ncbi.nlm.nih.gov/15601557/
- Europe PMC: https://europepmc.org/article/MED/15601557

## Connected records

- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [Oncolytic viruses](https://onco.cc/technologies/oncolytic-virus/)

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