Neoplasms

All Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Adenoviridae Infections

Communicable Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Virus Diseases

DNA Virus Infections

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Ethanol

Chlorotrianisene

Liver Extracts

Ethiodized Oil

TACE with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0\*1011vp：0.5ml\*3） will be first infused through the target artery of HCC patient and followed with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg) and lipiodol emulsion or/and polyvinyl alcohol particles(dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization)

After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0\*1011vp：0.5ml\*3） will be first infused through the target artery

Recombinant Human Adenovirus Type 5 Injection

Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

Transartery Chemoembolization

Ming Shi, MD

The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy.

Transarterial chemoembolization (TACE) is currently one of the mainstays of palliative treatments worldwide for patients with unresectable Hepatocellular Carcinoma(HCC).However, the long term outcomes were generally poor for HCC patients treated with TACE. Recombinant Human Adenovirus Type 5, an E1B gene deleted adenovirus, is known to have a significant antitumor activity. In addition, local injection of recombinant human adenovirus type 5 can enhance the effect of antitumor therapies (chemotherapy and radiotherapy). The hypothesis is that patients with unresectable HCC may benefit from recombinant human adenovirus type 5 in combination with TACE.

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Common Terminology Criteria for Adverse Events ( CTCAE )

Sun Yat-sen University

professor

The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.

The standard control group was the conventional RFA.Using RFA for the treatment of small HCC.The efficacy was compared with that of the experimental group combined with H101.

Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.

H101

Kai Feng, M.D

Kuansheng Ma, Ph.D

The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Some clinical trials have confirmed that H101(recombinant human adenovirus type 5 injection) has selective oncolysis in a variety of solid tumors.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.

The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Oncolytic virus H101 is a genetically engineered adenovirus that lacks Elb 55ku protein.Some clinical trials have confirmed that H101 has selective oncolysis in a variety of solid tumors.Furthermore,research shows that the directly dissolving tumor activity of H101 enhanced obviously and activate the body's anti-tumor immune to induce the distal antitumor effect under the condition of mild high temperature (40 ℃ and 42 ℃).The transition zone of RFA can provide the appropriate mild high temperature.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.

Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.

Radiofrequency Ablation Combined With Local Injection of Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma:A Multicenter Prospective Randomized Controlled Trial.

Postoperative tumor-free survival is an evaluation of tumor recurrence and metastasis.It's also an evaluation of the efficacy of the experimental group

The percentage of patients who receive certain treatments and are still alive after years of follow-up.

Southwest Hospital, China

Principal Investigator

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Tremelimumab

Complement C3

Complement C3d

1. Recombinant Human Type 5 Adenovirus Injection:

   Drug specification: 5.0 x 1011vp/0.5ml/stem. Dosage: Dilute with equal volume of saline before injection. For injection of lesions with a longest diameter ≥10mm and ≤40mm, 2 injections of recombinant human type 5 adenovirus injection per tumour, 1ml in total; for injection of lesions with a longest diameter ≥40mm and ≤80mm, 4 injections of recombinant human type 5 adenovirus injection per tumour, 2ml in total.
2. PD1 monoclonal antibody (Tremelimumab):

Dosage: 3mg/kg.

1. Recombinant Human Type 5 Adenovirus Injection:

   This is expected to be administered prior to immunotherapy, i.e. scheduled for injection at C1D1 (C2D1, C3D1, C4D1). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles.
2. PD1 monoclonal antibody (Tremelimumab):

Administered intravenously within 48h of recombinant human adenovirus type 5 injection, scheduled at C1D2 (C2D2, C3D2, C4D2). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles.

The goal of this clinical trial is provide new treatment for patients with advanced melanoma who have failed previous immunotherapy. The main questions it aims to answer are:

* Efficacy of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma.
* Safety of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma.

The study is divided into 5 phases: screening phase, washout phase, baseline phase, treatment phase and follow-up phase. Patients with advanced malignant melanoma who are eligible for screening and have failed previous anti-PD1 antibody therapy and who meet the inclusion exclusion criteria undergo elution with 1 PD1 monoclonal antibody injection, patients whose tumours progress after PD1 monoclonal antibody injection enter the treatment phase and are followed up every 1 month for at least 2 years in the follow-up phase.

PD-1 With Recombinant Human Adenovirus Type 5 Injection

An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas

PD-1 Monoclonal Antibody With Recombinant Human Adenovirus Type 5 Injection for the Treatment of Advanced Malignant Melanoma Patients Who Has Failed Immunotherapy: an Exploratory Single-arm Study

Adverse events should be reported during the trial and the incidence of adverse events such as fever, nausea and vomiting, leukopenia, thrombocytopenia, alopecia, diarrhea, and immune-related adverse events due to T-cell activation should be monitored. Monitor for immune-related adverse events caused by T-cell activation, such as immune dermatitis, pneumonia, colitis, uveitis, arthritis, nephritis, etc.

The proportion of CR and PR in all patients.

This refers to the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).

Time from the date of first treatment to the first event of disease progression or death from any cause, whichever occurs first, with the endpoint event determined by the investigator in accordance with RECIST v1.1.

Proportion of CR, PR and SD in all patients.

Time between the date of randomisation to the date of death from any cause or the end of the last follow-up visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma	NCT01869088	Hepatocellular ...	Recombinant Hum... Transartery Che...	18 Years - 70 Years	Sun Yat-sen University
Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.	NCT03790059	Hepatocellular ...	H101 RFA	18 Years - 75 Years	Southwest Hospital, China
An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas	NCT05928962	Malignant Melan...	Recombinant Hum...	18 Years - 75 Years	Fujian Cancer Hospital
Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.	NCT03790059	Hepatocellular ...	H101 RFA	18 Years - 75 Years	Southwest Hospital, China

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