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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR1210 in combination with paclitaxel and platinum in advanced esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.; Nanjing Geneseeq Technology Inc
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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, paclitaxel, cisplatin, 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 cisplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.