An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody

NCT ID: NCT04866381

Last Updated: 2021-04-29

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

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-04-30

Brief Summary

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This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma Progression to PD-1 Antibody

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-6390

SHR-6390

Group Type EXPERIMENTAL

SHR-6390

Intervention Type DRUG

SHR-6390

SHR-6390 combined with Camrelizumab (SHR-1210)

SHR-6390 combined with Camrelizumab (SHR-1210)

Group Type EXPERIMENTAL

SHR-6390 + Camrelizumab (SHR-1210)

Intervention Type DRUG

SHR-6390 combined with Camrelizumab (SHR-1210)

Camrelizumab (SHR-1210) combined with SHR-1020

Camrelizumab (SHR-1210) combined with SHR-1020

Group Type EXPERIMENTAL

Camrelizumab (SHR-1210) + SHR-1020

Intervention Type DRUG

Camrelizumab (SHR-1210) combined with SHR-1020

Interventions

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SHR-6390

SHR-6390

Intervention Type DRUG

SHR-6390 + Camrelizumab (SHR-1210)

SHR-6390 combined with Camrelizumab (SHR-1210)

Intervention Type DRUG

Camrelizumab (SHR-1210) + SHR-1020

Camrelizumab (SHR-1210) combined with SHR-1020

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
* Must have had progressive disease after previous treatment with PD-1 inhibitor
* ECOG score 0-2
* The expected survival time is ≥ 12 weeks
* Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade

Exclusion Criteria

* Had other active malignant tumors within 5 years before entering the study
* Had abnormal swallowing function or dysfunction of gastrointestinal absorption
* The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
* Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Facility Contacts

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Qingsong Pang, MD

Role: primary

+86-22-23340123-1121

Ting Deng, MD

Role: backup

+86-22-23340123-1051

Other Identifiers

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CIH-PQS-20210408

Identifier Type: -

Identifier Source: org_study_id

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