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

Tianjin Medical University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma; Progression to PD-1 Antibody

Treatments: Drug: Camrelizumab (SHR-1210) + SHR-1020; Drug: SHR-6390; Drug: SHR-6390 + Camrelizumab (SHR-1210)

Study type: Interventional

Funder types: Other

Identifiers

NCT04866381

CIH-PQS-20210408

Details and patient eligibility

About

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.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

SHR-6390

Experimental group

Description:

SHR-6390

Treatment:

Drug: SHR-6390

SHR-6390 combined with Camrelizumab (SHR-1210)

Experimental group

Description:

SHR-6390 combined with Camrelizumab (SHR-1210)

Treatment:

Drug: SHR-6390 + Camrelizumab (SHR-1210)

Camrelizumab (SHR-1210) combined with SHR-1020

Experimental group

Description:

Camrelizumab (SHR-1210) combined with SHR-1020

Treatment:

Drug: Camrelizumab (SHR-1210) + SHR-1020