NCT02429037

P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

Detailed description

To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.

Conditions

• Advanced Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	rAd-p53	multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle.
RADIATION	radiation	radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.
DRUG	Cisplatin	Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-04-29
• Last updated: 2015-04-29

Locations

1 site across 1 country: China