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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Esophageal Cancer
• Intervention / Treatment: Drug: Combination therapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hongying Liao, Professor; Phone Number: +86 13928845885; Email: hylmed1996@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Hongying Liao, Professor; Phone Number: 13928845885; Email: hylmed1996@126.com
      • Principal Investigator: Hongying Liao, Professor
      • Sub-Investigator: Yuzhen Zheng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Combination therapy; SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.	up to approximately 1 year
Overall Survival (OS)	Defined as the time from the enrollment to death from any cause	up to approximately 1 year
Disease Control Rate (DCR)	The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.	up to approximately 1 year
Adverse events (AEs)	All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03	up to approximately 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ESCC-IO-BIO-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No