Phase II study of Recombinant Adenovirus-Herpes Simplex Virus Thymidine Kinase (ADV-TK) combined with Ganciclovir in recurrent head and neck cancer of late-stage

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONRC-11001232

Enrollment

Unknown

Registered

2011-02-20

Start date

2007-12-21

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

Head and neck cancer in late-stage

Interventions

Group A:Recombinant Adenovirus-Herpes Simplex Virus Thymidine Kinase (ADV-TK) combined with Ganciclovir

Eligibility

Sex/Gender

All

Age

26 Years to 88 Years

Inclusion criteria

Inclusion criteria: 1. Recurrent head and neck cancer after surgery, chemotherapy and radiation therapy; 2. Single focus >=1cm or total foci =12 weeks; 7. Without metastatic focus in central nervous system; 8. ECGO scores 0-2;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.

Exclusion criteria

Exclusion criteria: 1. Allergic to ADV-TK and Ganciclovir or others; 2. Improper for local injection; 3. Accepting other anti-cancer therapy; 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

Measure	Time frame
Efficacy rate and control rate;	—

Secondary

Measure	Time frame
PFS, TTP and survival;	—

Countries

China

Contacts

Public ContactYuquan Wei, Ping Li

sztdk@163.com+86 13808192861

Outcome results

None listed

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