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A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

Primary Purpose

Advanced Esophageal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HR070803
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ECOG performance status 0 or 1
  2. Histologically confirmed advanced esophageal carcinoma
  3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
  4. Able and willing to provide a written informed consent

Exclusion Criteria:

  1. The tumor obviously invades adjacent organs of esophageal lesions
  2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening
  3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment
  4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HR070803

Arm Description

HR070803 monotherapy will be administered by intravenous infusion

Outcomes

Primary Outcome Measures

Objective response rate
The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.

Secondary Outcome Measures

Progression Free Survival
The study is designed to evaluate the progression free survival of HR070803 in patients with advanced esophageal cancer. PFS is defined as the time from first medication to disease progression or death, whichever is earlier
Disease Control Rate
The study is designed to evaluate the disease control rate of HR070803 in patients with advanced esophageal cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD)
Duration of Response
The study is designed to evaluate the duration of response of HR070803 in patients with advanced esophageal cancer. DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
Overall Survival
The study is designed to evaluate the overall survival of HR070803 in patients with advanced esophageal cancer. OS is defined as the time from first medication to death of any cause, censored for patients alive at data cut-off.
Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
Safety and tolerability will consist of monitoring and recording all AEs and SAEs as characterized by type, incidence, severity, and the relationship to the study therapy. AEs will be evaluated for all treated patients using NCI-CTCAE V5.0.
ECOG Score for performance status

Full Information

First Posted
June 1, 2022
Last Updated
September 2, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05425472
Brief Title
A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
Official Title
An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
HR070803 for all enrolled subjects
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR070803
Arm Type
Experimental
Arm Description
HR070803 monotherapy will be administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
HR070803
Intervention Description
HR070803
Primary Outcome Measure Information:
Title
Objective response rate
Description
The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.
Time Frame
for 4 months following the date the last patient was randomized
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
The study is designed to evaluate the progression free survival of HR070803 in patients with advanced esophageal cancer. PFS is defined as the time from first medication to disease progression or death, whichever is earlier
Time Frame
for 4 months following the date the last patient was randomized
Title
Disease Control Rate
Description
The study is designed to evaluate the disease control rate of HR070803 in patients with advanced esophageal cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD)
Time Frame
for 4 months following the date the last patient was randomized
Title
Duration of Response
Description
The study is designed to evaluate the duration of response of HR070803 in patients with advanced esophageal cancer. DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
Time Frame
for 4 months following the date the last patient was randomized
Title
Overall Survival
Description
The study is designed to evaluate the overall survival of HR070803 in patients with advanced esophageal cancer. OS is defined as the time from first medication to death of any cause, censored for patients alive at data cut-off.
Time Frame
for 6 months following the date the last patient was randomized
Title
Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
Description
Safety and tolerability will consist of monitoring and recording all AEs and SAEs as characterized by type, incidence, severity, and the relationship to the study therapy. AEs will be evaluated for all treated patients using NCI-CTCAE V5.0.
Time Frame
for 6 months following the date the last patient was randomized
Title
ECOG Score for performance status
Time Frame
for 6 months following the date the last patient was randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG performance status 0 or 1 Histologically confirmed advanced esophageal carcinoma At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1) Able and willing to provide a written informed consent Exclusion Criteria: The tumor obviously invades adjacent organs of esophageal lesions BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening Subjects with unresolved adverse effects of prior therapy at the time of enrolment Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoshuo Zhang
Phone
+0518-82342973
Email
xiaoshuo.zhang@hengrui.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

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