Esophageal Squamous Cell Carcinoma, Progression to PD-1 Antibody
Conditions
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.
Interventions
DRUGSHR-6390
SHR-6390
DRUGSHR-6390 + Camrelizumab (SHR-1210)
SHR-6390 combined with Camrelizumab (SHR-1210)
DRUGCamrelizumab (SHR-1210) + SHR-1020
Camrelizumab (SHR-1210) combined with SHR-1020
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Subject safety | Up to 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
Countries
China
Outcome results
None listed