Clinical trial NCT05174156: Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer
Official title: Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Esophageal Cancer
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Nanjing Geneseeq Technology Inc.
name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to approximately 1 year
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: up to approximately 1 year
measure: Overall Survival (OS)
timeFrame: up to approximately 1 year
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 1 year
measure: Adverse events (AEs)
timeFrame: up to approximately 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: