Liver cancer · Oncolytic virus + TACE
Oncolytic virus therapy for liver cancer,
H101 with TACE.
Unresectable hepatocellular carcinoma (HCC) is where H101 has the most published data beyond its approved indication. Chinese centres infuse it through the hepatic artery during TACE. In retrospective cohorts this produced higher response rates and longer survival than TACE alone, and the 2022 CSCO consensus recommends it as an option for initial treatment.
Quick answer
Can oncolytic virus therapy treat liver cancer?
In China, H101 is used as an add-on to TACE (transarterial chemoembolisation), which is off-label. For unresectable HCC with Child-Pugh A or B liver function and no spread outside the liver, the 2022 CSCO consensus says hepatic-artery H101 + TACE may be considered for initial treatment (graded 'recommended'). In a 175-patient retrospective study, complete response was 28.7% with the combination vs 14.8% with TACE alone. In a 476-patient matched cohort, 3-year survival was 40.5% vs 22.4%. Both studies are retrospective, not randomised.
28.7% vs 14.8%
Complete response
TACE + H101 (n=87) vs TACE (n=88), P = 0.017
Lin et al., BMC Cancer 2015
12.6% vs 25%
Progressive disease
P = 0.011
Lin et al., BMC Cancer 2015
12.8 vs 11.6 mo
Median overall survival
P = 0.046; PFS 10.49 vs 9.72 mo (P = 0.044)
Lin et al., BMC Cancer 2015
40.5% vs 22.4%
3-year survival
238 vs 238 matched; 1-yr 61.3 vs 53.8%, 2-yr 44.2 vs 33.4%
He et al., Chin J Cancer 2017
1,526 vs 1,236 d
Overall survival
149 vs 150 patients; PFS 240 vs 196 days
Dong et al., Med Oncol 2014
P > 0.05
Liver function
ALT, AST, bilirubin, WBC, Hb, platelets similar (post-resection cohort)
Wu et al., J Gastrointest Oncol 2021
Treatment pathway
From records review to response imaging.
1 · Remote records review
Contrast CT/MRI, AFP, liver function (Child-Pugh), kidney function, hepatitis status and prior treatment. The oncologist confirms whether the tumour is resectable and whether you are a candidate.
Before booking
2 · On-site assessment
Labs and imaging repeated if needed, specialist review and consent. Confirms the tumour is unresectable and that there is no extrahepatic spread.
At the hospital
3 · TACE + H101
In the Sun Yat-sen University studies, H101 (1.0×10¹² viral particles in 10 mL saline) was infused through the catheter into the hepatic artery supplying the tumour, alongside conventional chemoembolisation.
Interventional radiology
4 · Response imaging
The same studies assessed response with CT/MRI at 1 month, then every 3–4 months. Further treatment, such as repeat TACE, ablation, resection or systemic therapy, depends on response.
1 month, then 3–4 monthly
5 · Home follow-up
A bilingual report goes to your home oncologist and hepatologist. Hepatitis B antivirals continue as prescribed.
Ongoing
Evidence
Tumour response: TACE + H101 vs TACE alone
Lin et al. (BMC Cancer 2015) retrospectively compared consecutive patients with unresectable HCC treated at Sun Yat-sen University Cancer Center between April 2012 and April 2013. Response was assessed by three blinded radiologists using mRECIST.
| Response (mRECIST) | TACE + H101 (n=87) | TACE alone (n=88) | P value |
|---|---|---|---|
| Complete response (CR) | 28.7% | 14.8% | 0.017 |
| Partial response (PR) | 32.2% | 21.6% | 0.172 |
| Stable disease (SD) | 26.4% | 38.6% | 0.107 |
| Progressive disease (PD) | 12.6% | 25.0% | 0.011 |
90.2% of patients were hepatitis B positive. Among H101-treated patients, those receiving anti-HBV therapy responded similarly to those who were not (P = 0.162).
Survival
Survival in larger cohorts
He et al. (Chin J Cancer 2017) reviewed 590 patients with intermediate-to-advanced HCC treated at Sun Yat-sen University Cancer Center from 2007 to 2015. After propensity-score matching, 238 had TACE + H101 and 238 had TACE alone. In multivariable analysis, TACE with H101 was an independent factor for overall survival.
An earlier retrospective study from the same centre (Dong et al., Med Oncol 2014) compared 149 patients given H101 with TACE against 150 controls. Progression-free survival was 240 vs 196 days (P < 0.05) and overall survival 1,526 vs 1,236 days. Treatment-related adverse effects occurred at similar rates.
| Outcome | TACE + H101 (n=238) | TACE alone (n=238) |
|---|---|---|
| 1-year overall survival | 61.3% | 53.8% |
| 2-year overall survival | 44.2% | 33.4% |
| 3-year overall survival | 40.5% | 22.4% |
All differences P < 0.05. Retrospective, matched — not randomised.
Safety
Side effects of H101 + TACE
In Lin et al., the only side effect significantly more common with H101 was fever above 38.5 °C. Pain, ascites and acute renal failure occurred at similar rates, and no patient in either group developed encephalopathy. In a separate post-resection cohort (Wu et al., 2021), liver-function and blood-count measures did not differ significantly between the groups.
| Adverse effect | TACE + H101 | TACE alone | P value |
|---|---|---|---|
| Fever > 38.5 °C | 64.4% | 46.6% | 0.023 |
| Pain | 64.4% | 65.9% | 0.875 |
| Ascites | 26.4% | 25.0% | 0.864 |
| Acute renal failure | 5.7% | 4.5% | 0.896 |
| Encephalopathy | 0% | 0% | — |
After surgery
H101 + TACE after liver resection
Wu et al. (J Gastrointest Oncol 2021, Second Affiliated Hospital of Army Medical University) retrospectively studied HCC patients after surgery who received post-operative TACE with FOLFOX, with or without H101. Recurrence and metastasis rates were significantly lower with H101 (P < 0.05), and adverse-reaction rates were similar. The 2025 perioperative consensus still describes intra-operative oncolytic-virus use as exploratory.
Guidelines
What Chinese guidelines say
2022 CSCO expert consensus on recombinant oncolytic adenovirus: for HCC that cannot be resected, with Child-Pugh A or B liver function and no extrahepatic metastasis, hepatic-artery H101 combined with TACE may be considered as initial treatment (graded 'recommended'). The supporting retrospective studies are graded 3c in the consensus's evidence table. The patients in them also had serum creatinine below 140 µmol/L and BUN within the normal range.
2023 Chinese consensus on intra-arterial drug administration for primary HCC: discusses oncolytic viruses under 'new approaches' to intra-arterial combination therapy.
2025 perioperative immunotherapy consensus, Recommendation 19: intra-operative immunotherapy for HCC is still at an exploratory stage, and local perfusion of an oncolytic virus may help control local recurrence (evidence IIb, grade C recommendation).
Published research
Liver cancer centres
with published H101 research.
Sun Yat-sen University Cancer Center 中山大学肿瘤防治中心
Three retrospective H101 + TACE cohorts: 299 patients (Med Oncol 2014), 175 (BMC Cancer 2015), 476 matched (Chin J Cancer 2017)
Fudan University Shanghai Cancer Center 复旦大学附属肿瘤医院
H101 + nivolumab in refractory advanced HCC — pilot, n=18 (ESMO Open 2024)
Second Affiliated Hospital of Army Medical University 陆军军医大学第二附属医院
H101 + TACE after resection: recurrence and metastasis (J Gastrointest Oncol 2021)
FAQ
H101 for liver cancer — answered.
- Who is a candidate for H101 + TACE?
- The 2022 CSCO consensus describes candidates as having HCC that cannot be removed surgically, Child-Pugh A or B liver function and no spread outside the liver. Patients in the supporting studies also had serum creatinine below 140 µmol/L and BUN within normal limits. Final candidacy is decided by the treating oncologist.
- Is H101 + TACE better than TACE alone?
- In retrospective Chinese cohorts, it produced more complete responses (28.7% vs 14.8%) and fewer progressions (12.6% vs 25%). Median overall survival was modestly longer (12.8 vs 11.6 months), and 3-year survival was higher in a matched cohort (40.5% vs 22.4%). None of these were randomised trials, so some of the difference may reflect patient selection.
- Can I keep taking hepatitis B antivirals?
- Continue HBV antivirals as directed by your hepatologist. In Lin et al., where 90.2% of patients were HBV-positive, response to H101 did not differ significantly between patients who did and did not receive anti-HBV therapy (P = 0.162).
- Does H101 damage the liver?
- In a post-resection cohort comparing TACE + H101 with TACE alone, peak ALT, AST, total and direct bilirubin and white-cell count did not differ significantly. Nor did the lowest haemoglobin and platelet counts (all P > 0.05). In Lin et al., no patient developed hepatic encephalopathy. TACE itself can temporarily affect liver function, and this is monitored.
- How long do I need to stay in China?
- It depends on the plan your oncologist proposes. In the Sun Yat-sen University studies, response was first assessed by CT/MRI one month after treatment, and many patients then received further treatments such as repeat TACE. We'll outline the expected stay, and whether return visits are practical, once the oncologist has reviewed your records.
- Is H101 used for liver metastases from other cancers or for cholangiocarcinoma?
- These uses are investigational. At ASCO 2024, Chinese investigators presented a Phase II study (TROJAN 021) of H101 with checkpoint inhibitors in liver-metastatic gastric cancer. They also presented a single-arm study of an oncolytic virus with HAIC-mFOLFOX in intrahepatic mass-forming cholangiocarcinoma. Candidacy outside HCC is assessed case by case.
Related guides
Oncolytic Virus Therapy (hub)
Overview: what it is, who it may suit, how it's used in China.
Read the guideOncorine (H101) drug profile
Approval, genetic construct, approved indication and milestones.
Read the guideHow oncolytic viruses work
Selective replication, tumour lysis and turning 'cold' tumours 'hot'.
Read the guideH101 + PD-1 immunotherapy
Combination data, malignant ascites and immune-microenvironment changes.
Read the guideSafety & side effects
Adverse-event rates from the Phase III trial and combination studies.
Read the guideLiver disease in China
Cirrhosis, hepatitis and liver-transplant pathways.
Read the guideSources
References
- Lin XJ, Li QJ, Lao XM, Yang H, Li SP. Transarterial injection of recombinant human type-5 adenovirus H101 in combination with transarterial chemoembolization (TACE) improves overall and progressive-free survival in unresectable hepatocellular carcinoma (HCC). BMC Cancer. 2015;15:707.
- He CB, Lao XM, Lin XJ. Transarterial chemoembolization combined with recombinant human adenovirus type 5 H101 prolongs overall survival of patients with intermediate to advanced hepatocellular carcinoma: a prognostic nomogram study. Chin J Cancer. 2017;36(1):59.
- Dong J, et al. Gene therapy for unresectable hepatocellular carcinoma using recombinant human adenovirus type 5. Med Oncol. 2014;31(8):95.
- Wu K, You N, Zheng L. Effects of recombinant human adenovirus type 5 combined with transarterial chemoembolization on postoperative metastasis and recurrence of hepatocellular carcinoma patients. J Gastrointest Oncol. 2021;12(6):2999–3007.
- Yi L, Ning Z, Xu L, et al. The combination treatment of oncolytic adenovirus H101 with nivolumab for refractory advanced hepatocellular carcinoma: an open-label, single-arm, pilot study. ESMO Open. 2024;9(2):102239.
- CSCO Immunotherapy Expert Committee; Shanghai Anti-Cancer Association Tumor Biotherapy Committee. 基因重组溶瘤腺病毒治疗恶性肿瘤临床应用中国专家共识(2022年版). China Oncology (中国癌症杂志). 2023;33(5). doi:10.19401/j.cnki.1007-3639.2023.05.013
- Interventional Drug Group, Interventional Physicians Branch, Chinese Medical Doctor Association. 原发性肝细胞癌经动脉内用药与联合用药中国专家共识. Chinese Journal of Internal Medicine. 2023;62(7):785–801. doi:10.3760/cma.j.cn112138-20230202-00049
- 肝细胞癌围手术期免疫治疗多学科协作专家共识(2025版). Chinese Journal of Digestive Surgery. 2025;24(6):678–689. doi:10.3760/cma.j.cn115610-20250609-00278
- ASCO 2024 Annual Meeting, J Clin Oncol 2024;42(16_suppl): abstract 2635 (Yuan M et al., TROJAN 021 — H101 + immune checkpoint inhibitors in liver-metastatic gastric cancer, Phase II); abstract 5536 (Zhang Q et al., intratumoral H101 in persistent/recurrent/metastatic gynecological cancer); abstract e16265 (Wang T et al., oncolytic virus + HAIC of mFOLFOX for intrahepatic mass-forming cholangiocarcinoma).
Send your liver imaging
for a TACE + H101 review.
Share contrast CT/MRI, AFP, liver-function tests and your treatment history. A partner hepatobiliary oncologist will reply in writing on whether you meet the criteria for H101 + TACE, the likely treatment plan and an itemised cost, plus alternatives if you don't qualify.
This page is for general education only and is not medical advice. Oncolytic virus therapy is not suitable for every patient or every cancer. In China, Oncorine (H101) is approved only for advanced nasopharyngeal carcinoma in combination with chemotherapy; other uses described here are supported by retrospective studies, small trials, conference abstracts or expert consensus rather than large randomised trials. Treatment decisions are made by the treating oncologist after reviewing your records. We are an independent patient-coordination service and are not affiliated with the manufacturer.