Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Cancer Cervical Cancer Endometrial Cancer

Keywords

Oncolytic virusHerpes simplex virus typeⅠImmunotherapy

Outcome Measures

Primary Outcomes (2)

Adverse Events
All serious and non-serious adverse events that occur after enrollment through 7 (+14) days after the last administration of R130 will be recorded
Up to 6 months
Systemic immune response
Detection of increased systemic immune Response markers in sera,ascites and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Up to 6 months

Secondary Outcomes (3)

Disease Assessment for Disease Control Rate
Every 10 weeks for 12 months
Disease Assessment for Duration of Response
Every 10 weeks for 12 months
Quality of Life Assessment
Every 6 weeks for 12 months

Study Arms (1)

R130 Treatment Group

EXPERIMENTAL

Every 7-14 days,1-4 ml R130 （concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory cervical and endometrial Cancer.

Drug: Recombinant oncolytic herpes simplex virus type Ⅰ (R130)

Interventions

Recombinant oncolytic herpes simplex virus type Ⅰ (R130)Drug

R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

Also known as: Oncolytic virus Injection

R130 Treatment Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with cervical cancer or endometrial cancer clearly diagnosed by histology and/or cytology.
Failure of standard treatment or patient unwillingness to receive other antitumor therapy.

Sponsors & Collaborators

Shanghai Yunying Medical Technology
Industrylead
Shanghai 10th People's Hospital
Othercollaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Jing Guo, PhdCONTACT+86 18817821547 jguo12@foxmail.com

Zhongping Cheng, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Feng Pan

CONTACT

+86 13764868528 pf@jxyymedtech.com

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 14, 2023

Study Start

February 6, 2023

Actual (reported)

Primary Completion

February 6, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

R130 Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

R130 Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations