NCT05174156UnknownPhase 2
Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer
Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country50 target enrollmentStarted: January 1, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
Brief Summary
This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
- •Not received any previous systematic antitumor therapy.
- •Eastern Cooperative Oncology Group (ECOG) fitness status score was 0 or 1 within 3 days before the first administration of the intervention.
- •8-10 tumor tissue samples can be provided.
- •Demonstrate good organ and bone marrow function.
- •Consent to participate in the contraceptive methods related to clinical research.
Exclusion Criteria
- •Have a history of allergy to monoclonal antibodies, any component of SHR-1210, albumin-paclitaxel, carboplatin, and other platinum drugs;
- •Weight loss > 20% in the past 3 months.
- •Major surgery within 28 days prior to enrollment.
- •Have received systemic chemotherapy or radiation therapy for esophageal cancer.
- •Had a myocardial infarction within the past 6 months.
- •Have any medical history or current evidence, treatment, or laboratory abnormalities that prevent the subject from participating fully in the study with the investigator's opinion.
- •Prior treatment with immunotherapy drugs.
- •Received live vaccine within 30 days prior to initial administration of the investigational drug.
- •Have been diagnosed with immunodeficiency or are receiving immunosuppressive treatment.
- •Another malignancy is known to exist.
- •Have active infections that require systemic treatment.
- •Pregnant or lactating, or planning to become pregnant or become a father during the study period (180 days for lactating subjects receiving carboplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.
Arms & Interventions
biomarker study and treatment study
Experimental
All enrolled patients undergo biomarker study and treatment study.
- Biomarker study: the baseline tumor tissue will be collected and analyzed via NGS and mIHC
- Treatment study: SHR-1210 plus albumin-bound paclitaxel and platinum-based chemotherapy
Intervention: Combination therapy (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: up to approximately 1 year
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Secondary Outcomes
- Progression-Free Survival (PFS)(up to approximately 1 year)
- Disease Control Rate (DCR)(up to approximately 1 year)
- Overall Survival (OS)(up to approximately 1 year)
- Adverse events (AEs)(up to approximately 1 year)
Investigators
Study Sites (1)
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