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

NCT ID: NCT05425472

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2023-03-30

Brief Summary

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

Detailed Description

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Conditions

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Advanced Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

HR070803 for all enrolled subjects
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HR070803

HR070803 monotherapy will be administered by intravenous infusion

Group Type EXPERIMENTAL

HR070803

Intervention Type DRUG

HR070803

Interventions

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HR070803

HR070803

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoshuo Zhang

Role: CONTACT

+0518-82342973

Other Identifiers

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HR070803-201

Identifier Type: -

Identifier Source: org_study_id

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