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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04866381
• Other study ID #: CIH-PQS-20210408
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: April 2023

Study information

• Verified date: April 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 87
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Disease Progression
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• SHR-6390
SHR-6390
• SHR-6390 + Camrelizumab (SHR-1210)
SHR-6390 combined with Camrelizumab (SHR-1210)
• Camrelizumab (SHR-1210) + SHR-1020
Camrelizumab (SHR-1210) combined with SHR-1020

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Objective Response Rate is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria.	1 year
Secondary	Progression-Free-Survival	Progression-Free-Survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first.	Up to 1 year
Secondary	Overall survival	Overall survival is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date.	Up to 1 year
Secondary	Subject safety	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	Up to 1 year