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Phase II study of Recombinant Adenovirus-Herpes Simplex Virus Thymidine Kinase (ADV-TK) combined with Ganciclovir in primary hepatocellular carcinoma

Phase II study of Recombinant Adenovirus-Herpes Simplex Virus Thymidine Kinase (ADV-TK) combined with Ganciclovir in primary hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-11001233
Enrollment
Unknown
Registered
2011-02-20
Start date
2007-11-29
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hepatocellular carcinoma in late stage

Interventions

Sponsors

Shenzhen Tiandakang Gene Engineering Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
29 Years to 73 Years

Inclusion criteria

Inclusion criteria: 1. Recurrent cancer after surgery or other therapies; 2. Histopathological diagnosis is confirmed according to AASLD standard; 3. Single focus =5cm or total foci =18 years old; 6. ECGO scores =12 weeks; 8. Without metastatic focus except the liver; 9. ANC >=1.5*10^9/L, PLT >=80*10^9/L, TBI<=1.5*upper limit of normal, ALT/AST <=2*upper limit of normal and APTT and PT are normal one week before; 10. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to ADV-TK and Ganciclovir or others; 2. Severe cirrhosis (Child C), hepatatrophy, portal hypertension or serious ascites; Improper for local injection; 3. Diffuse liver cancer, cancer embolus, obstructive jaundice, liver failure and uncontrolled hepatic encephalopathy; 4. Serious coagulation abnormality and hemorrhagic tendency; 5. Serious diseases of internal medicine, recent acute myocardial infarction or acute infection; 6. Pregnant or breast-feeding women; 7. Other conditions improper for the trial.

Design outcomes

Primary

MeasureTime frame
Control rate;

Secondary

MeasureTime frame
PFS, TTP and survival;

Countries

China

Contacts

Public ContactYuquan Wei, You Lu
sztdk@163.com+86 28 85423571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026