Advanced Esophageal Cancer
Conditions
Brief summary
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
Interventions
DRUGHR070803
HR070803
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HR070803 for all enrolled subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | for 4 months following the date the last patient was randomized | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | for 4 months following the date the last patient was randomized | 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 | for 4 months following the date the last patient was randomized | 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 | for 4 months following the date the last patient was randomized | 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 | for 6 months following the date the last patient was randomized | 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 | for 6 months following the date the last patient was randomized | 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 | for 6 months following the date the last patient was randomized | — |
Countries
China
Contacts
Primary ContactXiaoshuo Zhang
Outcome results
None listed