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

Study Overview
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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.

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

Conditions
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Esophageal Squamous Cell Carcinoma, Progression to PD-1 Antibody

Intervention / Treatment
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* Drug: SHR-6390
* Drug: SHR-6390 + Camrelizumab (SHR-1210)
* Drug: Camrelizumab (SHR-1210) + SHR-1020


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-6390<br>SHR-6390 | Drug: SHR-6390<br>* SHR-6390<br>|
| Experimental: SHR-6390 combined with Camrelizumab (SHR-1210)<br>SHR-6390 combined with Camrelizumab (SHR-1210) | Drug: SHR-6390 + Camrelizumab (SHR-1210)<br>* SHR-6390 combined with Camrelizumab (SHR-1210)<br>|
| Experimental: Camrelizumab (SHR-1210) combined with SHR-1020<br>Camrelizumab (SHR-1210) combined with SHR-1020 | Drug: Camrelizumab (SHR-1210) + SHR-1020<br>* Camrelizumab (SHR-1210) combined with SHR-1020<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Subject safety | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | Up to 1 year |