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

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

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.

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.