Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Advanced Esophageal Cancer

Treatments: Drug: Combination therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05174156

ESCC-IO-BIO-1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

biomarker study and treatment study

Experimental group

Description:

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

Treatment:

Drug: Combination therapy