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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

NCT03691090

Advanced Esophageal Cancer

COMPLETED PHASE3

A Phase II Study of SHR-1210 vs Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Locally Advanced ESCC

NCT03817658

Esophageal Squamous Cell Carcinoma

UNKNOWN PHASE2

Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy

NCT06746961

Esophageal Squamous Cell Carcinoma (ESCC)

NOT_YET_RECRUITING PHASE1/PHASE2

A Study to Evaluate the Safety and Efficacy of SHR-1210, Gemcitabine and Cis-platinum by R/M NPC Subjects

NCT03121716

Nasopharyngeal Carcinoma

COMPLETED PHASE1

SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.

NCT03558191

Nasopharyngeal Carcinoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Combination therapy

Intervention Type DRUG

SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Combination therapy

SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No