NCT03099382

Brief Summary

In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 28, 2017

Results QC Date

April 26, 2023

Last Update Submit

April 26, 2023

Conditions

Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    approximately 24 months

Study Arms (2)

camrelizumab

EXPERIMENTAL
Biological: camrelizumab

Investigator's Choice of Standard Therapy

ACTIVE COMPARATOR

Docetaxel or Irinotecan

Drug: DocetaxelDrug: Irinotecan

Interventions

camrelizumabBIOLOGICAL

Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks

Also known as: SHR-1210
camrelizumab
DocetaxelDRUG

Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks

Investigator's Choice of Standard Therapy
IrinotecanDRUG

Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks

Investigator's Choice of Standard Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 18-75 years, male or female.
  • Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease, recurrent or Metastatic disease.
  • Fail to the first-line standard therapy.
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • Can provide either a newly obtained or archival tumor tissue sample.
  • ECOG 0-1.
  • Life expectancy of greater than 12 weeks.
  • Adequate organ function.
  • Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210 or through 180 days after the last dose of docetaxel or irinotecan.
  • Patient has given written informed consent.

You may not qualify if:

  • Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
  • Known central nervous system (CNS) metastases.
  • Subjects with any active autoimmune disease or history of autoimmune disease.
  • Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
  • Active infection or an unexplained fever \> 38.5°C before two weeks of randomization (subjects with tumor fever may be enrolled at the discretion of the investigator);
  • History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
  • Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C.
  • BMI, \<18.5mg/m2 or ≥10% weight lost before screening.
  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
  • Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation, allergy, hypersensitivity, or contraindication to docetaxel, or irinotecan.
  • Concurrent medical condition requiring the use of cortisol ( \>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy.
  • Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
  • Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
  • Received a live vaccine within 4 weeks of the first dose of study medication.
  • Pregnancy or breast feeding.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

307 Hospital of PLA

Beijing, Beijing Municipality, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Huang J, Xu J, Chen Y, Zhuang W, Zhang Y, Chen Z, Chen J, Zhang H, Niu Z, Fan Q, Lin L, Gu K, Liu Y, Ba Y, Miao Z, Jiang X, Zeng M, Chen J, Fu Z, Gan L, Wang J, Zhan X, Liu T, Li Z, Shen L, Shu Y, Zhang T, Yang Q, Zou J; ESCORT Study Group. Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2020 Jun;21(6):832-842. doi: 10.1016/S1470-2045(20)30110-8. Epub 2020 May 13.

    PMID: 32416073DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumabDocetaxelIrinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Shiwei Sun; Project Manager
Organization
Jiangsu HengRui Pharmaceuticals Co., Ltd.
shiwei.sun@hengrui.com
+86-18036618554

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

May 5, 2017

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

January 22, 2024

Results First Posted

January 22, 2024

Record last verified: 2023-04

Locations

CN(2)