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

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

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

Conditions
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Advanced Esophageal Cancer

Intervention / Treatment
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* Drug: HR070803


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: HR070803 for all enrolled subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR070803<br>HR070803 monotherapy will be administered by intravenous infusion | Drug: HR070803<br>* HR070803<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| ECOG Score for performance status |  | for 6 months following the date the last patient was randomized |