NCT05425472UnknownPhase 2
An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country30 target enrollmentStarted: July 27, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective response rate
Study Overview
Brief Summary
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HR070803
Experimental
HR070803 monotherapy will be administered by intravenous infusion
Intervention: HR070803 (Drug)
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 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 Outcomes
- 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)
- 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)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)Autism Spectrum Disorder (ASD)NCT04299464Hoffmann-La Roche104
Terminated
Phase 2
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the LungNon Small Cell Lung CancerNCT02485652Hanmi Pharmaceutical Company Limited162
Recruiting
Phase 1
Q702 for the Treatment of Patients With Hematologic MalignanciesPrimary Central Nervous System LymphomaNCT06712810Mayo Clinic46
Completed
Phase 2
HR021618 in Moderate to Severe Pain After Abdominal SurgeryPain After Abdominal SurgeryNCT04811053Jiangsu HengRui Medicine Co., Ltd.60
Recruiting
Phase 1
Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast CancerBreast CancerNCT06222879Shandong Suncadia Medicine Co., Ltd.350