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

Phase 2

• Conditions: Advanced Esophageal Cancer
• Interventions: Drug: HR070803

• Registration Number: NCT05425472
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-07-27
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-06
• Primary Completion: 2023-01-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HR070803	HR070803	HR070803 monotherapy will be administered by intravenous infusion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China