Neoplasms

All Conditions

Infections

Digestive System Diseases

Carcinoma

Virus Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks; Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

This is a prospective, multicenter, open, randomized controlled Phase II clinical study to evaluate the efficacy and safety of intratumoral injection of OH2 combined with capecitabine for first-line maintenance of advanced colorectal cancer.

First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer

A Prospective, Multicenter, Open, Randomized Controlled Phase II Clinical Study Evaluating Recombinant Oncolytic HSV2（OH2）Therapeutic Injecta(Vero Cell) for Human Use(rHSV2hGM-CSF) in Combination With Capecitabine for First-line Maintenance Therapy in Advanced Colorectal Cancer

Time after treatment to clinical and radiographic disease progression will be evaluated.

objective response lasting continuously 6 months

The overall survival for each patient receiving treatment will be calculated.

Determination of the ORR will be calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and iRECIST as assessed by investigators.

DCR will be calculated based on the proportion of patients achieving CR, PR, or who have SD at least 6 weeks after receiving first dose of study treatment.

DOR will be calculated from the time of initial response (CR or PR) documentation to the time of progressive disease (PD). If a subject who had CR or PR dies without the evidence of disease progression, the case will be censored at the time point of death when analyzing DOR

Time after treatment to disease progression using the iRECIST will be evaluated.

Safety assessments should be conducted for all subjects who received treatment at least once. Adverse events will be graded according to CTCAE v5.0.

Binhui Biopharmaceutical Co., Ltd.

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Temozolomide

Dacarbazine

Taxane

OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks;

Salvage chemotherapy (single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum) or best supportive care selected by the investigator

single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum

Salvage chemotherapy or best supportive care

Wentao Xu

To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls.

OH2 Injection in Melanoma

To Evaluate a Phase III Study of OH2 Versus Investigator-selected Salvage Chemotherapy or Best Supportive Care in Melanoma Patients Who Had Failed Standard Therapy

Overall survival is defined as the interval from first dose to death from any cause.

Determination of the ORR is calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and iRECIST as assessed by investigators.

DCR is defined as the percentage of participants with a best overall response of CR, PR, or SD.

Progression-free survival is defined as the time from first dose to the earlier event of confirmed PD or death from any cause.

DRR is defined as the percentage of participants with a best overall response of CR or PR using the RECIST/iRECIST assessment with a duration of response of at least 6 months.

DOR is defined as the time from the first recording of remission (CR or PR) to the first recording of disease progression or death (whichever comes first)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer	NCT05648006	Advanced Colore...	OH2 Capecitabine Bevacizumab	17 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.
OH2 Injection in Melanoma	NCT05868707	Melanoma	OH2 Salvage chemoth...	18 Years -	Binhui Biopharmaceutical Co., Ltd.
First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer	NCT05648006	Advanced Colore...	OH2 Capecitabine Bevacizumab	17 Years - 75 Years	Binhui Biopharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for oh2

Every month we try and update this database with for oh2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oh2

Every month we try and update this database with for oh2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oh2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.