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

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma; Progression to PD-1 Antibody
• Interventions: Drug: SHR-6390; Drug: SHR-6390 + Camrelizumab (SHR-1210); Drug: Camrelizumab (SHR-1210) + SHR-1020

• Registration Number: NCT04866381
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-6390	SHR-6390	SHR-6390
SHR-6390 combined with Camrelizumab (SHR-1210)	SHR-6390 + Camrelizumab (SHR-1210)	SHR-6390 combined with Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) combined with SHR-1020	Camrelizumab (SHR-1210) + SHR-1020	Camrelizumab (SHR-1210) combined with SHR-1020

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Subject safety	Up to 1 year	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Progression-Free-Survival	Up to 1 year	Progression-Free-Survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first.
Overall survival	Up to 1 year	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.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China