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 enrollmentJanuary 1, 2022

ConditionsAdvanced Esophageal Cancer

InterventionsCombination therapy

DrugsCombination therapy

Overview

Phase: Phase 2
Intervention: Combination therapy
Conditions: Advanced Esophageal Cancer
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Enrollment: 50
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2022

End Date

December 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party

Sponsor

Eligibility 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, 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.

Arms & Interventions

biomarker study and treatment study

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

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.