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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    50
  • sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
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Updated on 4 October 2022
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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.

Details
Condition Advanced Esophageal Cancer
Treatment Combination Therapy, SHR-1210 + paclitaxel + cisplatin
Clinical Study IdentifierNCT05174156
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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