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

Advanced Esophageal Cancer Clinical Trial

Official title:

An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425472
• Other study ID #: HR070803-201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Xiaoshuo Zhang
• Phone: +0518-82342973
• Email: xiaoshuo.zhang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• HR070803
HR070803

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	for 4 months following the date the last patient was randomized
Secondary	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	for 4 months following the date the last patient was randomized
Secondary	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)	for 4 months following the date the last patient was randomized
Secondary	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.	for 4 months following the date the last patient was randomized
Secondary	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.	for 6 months following the date the last patient was randomized
Secondary	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.	for 6 months following the date the last patient was randomized
Secondary	ECOG Score for performance status		for 6 months following the date the last patient was randomized