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

Advanced Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174156
• Other study ID #: ESCC-IO-BIO-1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Hongying Liao, Professor
• Phone: +86 13928845885
• Email: hylmed1996[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Combination therapy
SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Jiangsu HengRui Medicine Co., Ltd., Nanjing Geneseeq Technology Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival (OS)	Defined as the time from the enrollment to death from any cause	up to approximately 1 year
Secondary	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
Secondary	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