A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
July 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedSeptember 6, 2022
June 1, 2022
6 months
June 1, 2022
September 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Progression Free Survival
for 4 months following the date the last patient was randomized
Disease Control Rate
for 4 months following the date the last patient was randomized
Duration of Response
for 4 months following the date the last patient was randomized
Overall Survival
for 6 months following the date the last patient was randomized
Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
for 6 months following the date the last patient was randomized
- +1 more secondary outcomes
Study Arms (1)
HR070803
EXPERIMENTALHR070803 monotherapy will be administered by intravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 21, 2022
Study Start
July 27, 2022
Primary Completion
January 30, 2023
Study Completion
March 30, 2023
Last Updated
September 6, 2022
Record last verified: 2022-06