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

NCT05174156 | Unknown Phase 2

• 1 other identifier: ESCC-IO-BIO-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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.

  up to approximately 1 year

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  up to approximately 1 year

• Overall Survival (OS)

  up to approximately 1 year

• Disease Control Rate (DCR)

  up to approximately 1 year

• Adverse events (AEs)

  up to approximately 1 year

Study Arms (1)

biomarker study and treatment study

EXPERIMENTAL

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

Drug: Combination therapy

Interventions

Combination therapy DRUG

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

biomarker study and treatment study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• tumor tissue samples can be provided.
• Demonstrate good organ and bone marrow function.
• Consent to participate in the contraceptive methods related to clinical research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Nanjing Geneseeq Technology Inc.: collaborator
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Interventions

Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hongying Liao, Professor

CONTACT

+86 13928845885; hylmed1996@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 30, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

CN (1)