Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

rAd-p53 gene

surgery

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

p53 gene therapy

p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

p53 gene therapy with radioactive iodine

aiqi wang, MD

Jingqiang Zhu, PhD, MD

Jingqiang Zhu, MD,PhD

This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with with concurrent radioactive iodine, or combination with surgery for treatment of advanced malignant thyroid tumors(stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).

The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with radioactive iodine,or surgery.

rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Radioactive Iodine , or Combination With Surgery in Subjects With Advanced Malignant Thyroid Tumors

Shenzhen SiBiono GeneTech Co.,Ltd

p53 gene therapy with concurrent chemotherapy

Intra-tumor injectio of rAd-p53 gene with no concurrent treatment

p53 gene with surgery

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy

p53 with chemotherapy

qing yu, MD

Longjiang Li, PhD, MD

This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors(stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).

The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with chemotherapy,or surgery.

rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors

Nutritional and Metabolic Diseases

Digestive System Diseases

Diabetes Mellitus

Carcinoma

Carcinoma, Hepatocellular

Metabolic Diseases

Glucose Metabolism Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month

Trans-catheter embolization (TAE) will be given once per month

Trans-catheter embolization

Yuewei Zhang, MD, Ph D

Gui Gao, MD, Ph D

An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).

It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.

p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

In 60 days after starting study treatment

overall survival will be follow up to 2 years. Time to an event (death), or censored status (lost of follow up, withdrawal from the study, or still alive on 2 years) will be recorded. OS will be estimated using Kaplan-Meier method.

PFS will be follow up to 2 years. Time to an event (progression or death) or censored status (lost of follow up, withdrawal from the study, or still alive and no progression on 2 years). Assessment of progression will follow RECIST standard Version 1.1. PFS will be estimated using Kaplan-Meier method.

from starting treatment until 60 days treatment

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy

Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy

Surgery combined with rAd-p53 gene therapy

Surgery

Qunyou Tan, M.D., Ph.D

Qunyou Tang, M.D., Ph.D

qunyou tan, M.D., Ph.D

The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects.

The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors	NCT00902122	Advanced Malign...	rAd-p53 gene surgery p53 gene therap... p53 gene therap...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors	NCT00902083	Advanced Oral a...	p53 gene with s... surgery p53 with chemot... p53 gene therap...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma	NCT02561546	HCC Diabetes	p53 gene therap... Trans-catheter ...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma	NCT02561546	HCC Diabetes	p53 gene therap... Trans-catheter ...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma	NCT01574729	Non-small Cell ...	Surgery combine... Surgery	18 Years -	Shenzhen SiBiono GeneTech Co.,Ltd
rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors	NCT00902083	Advanced Oral a...	p53 gene with s... surgery p53 with chemot... p53 gene therap...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma	NCT01574729	Non-small Cell ...	Surgery combine... Surgery	18 Years -	Shenzhen SiBiono GeneTech Co.,Ltd
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors	NCT00902122	Advanced Malign...	rAd-p53 gene surgery p53 gene therap... p53 gene therap...	18 Years - 85 Years	Shenzhen SiBiono GeneTech Co.,Ltd

Spots Global Cancer Trial Database for p53 gene therapy