Skip to content

rAd-p53 combined chemotherapy via selective arterial cannula in the treatment of advanced oral cancer, a randomized controlled trial

rAd-p53 combined chemotherapy via selective arterial cannula in the treatment of advanced oral cancer, a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000392
Enrollment
Unknown
Registered
2009-05-18
Start date
2003-01-01
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

Oral cancer

Interventions

Group A:Selective arterial cannula rAd-p53: 1*10^12/site/time, 4 days one time, total 10 times
selection of chemotherapy drug depends on the type of cancer, two days latter of the gene therapy
8 days a cycle, total two cycles
7 days stop between two cycles
Group B:Selective arterial cannula rAd-p53: 1*10^12/side/time
4 days a time
total 10 times.
Group C:Selection of chemotherapy drugs will be made according to the cancer type
the treatment to be started after two days of gene therapy
8 days a cycle, total two cycles, 7 days stop between two cycles.

Sponsors

West China Stomatology Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patients with oral cancer to be III, IV stage (WHO 2005 version);2. Not received any treatment previously;3. 18~80 years old;4. Expected survival =6 months;5. ECOG scores 0~1;6. WBC=3.5×109/L, neutrophilic granulocyte =2.0×109/L,PLT=100.0×109/L,HGb=90g/L;7. Normal liver function include bilirubin, ?-GT, ALP and LDH; SGOT and SGPT no higher than 2.5 times of normal value;8. Renal function: creatinine concentration no higher than 1.25 times of normal value;9. Heart function 0-2 scale;10. Signed the formal consent.

Exclusion criteria

Exclusion criteria: 1. Complicated with severe systematic diseases, such as cardiovascular diseases, uncontrolled infectious diseases, systematic immune deficiency, etc.; 2. To be treated by radiotherapy, chemotherapy, surgery or other remedies; 3. Any reason will lead to unable to complete the systematic therapy; 4. To be poor compliance.

Design outcomes

Primary

MeasureTime frame
P53, Bax and bcl-2 expression;Clinical efficacy;

Secondary

MeasureTime frame
Antibody concentration;

Contacts

Public ContactLongjiang Li
Muzili63@163.com+86 028 85501440

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 8, 2026