Combination of Chemotherapy Plus RT and SHR-1210 to Treat Patients With ESCC

January 7, 2019 updated by: Tianjin Medical University Cancer Institute and Hospital

A Single Arm Exploratory Study of Chemotherapy Plus Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Locally Advanced Esophageal Squamous Cell Carcinomas

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an openlabel，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 and chemotherapy in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. age:18-75 years, male or female.
  2. Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
  3. Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  5. ECOG 0-1.
  6. Adequate organ function.
  7. Life expectancy of greater than 6 months.
  8. Patient has given written informed consent.

Exclusion Criteria:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
  3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);

  4. Subjects with any active autoimmune disease or history of autoimmune disease

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  5. 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;
  6. Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
  7. Received a live vaccine within 4 weeks of the first dose of study medication.
  8. Pregnancy or breast feeding.
  9. Decision of unsuitableness by principal investigator or physician-incharge.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SHR-1210 + Chemotherapy + Radiotherapy

Radiotherapy(IMRT or VMAT): 95%PTV 54Gy/30 fraction,95%PTV 60Gy/30 fraction ,5 fractions per week, for 6 weeks. Radiation begun the day on which first dose of SHR-1210.

SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes.

Chemotherapy: Docetaxel 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22, total 4 cycles; Cisplatin 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22;, total 4 cycles.

Apatinib: 250mg/d，PO Qd(4 weeks after Radiotherapy, until the end of 8th ycle )
Drug: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Other Names:
  • Anti-PD-1 Antibody
Radiation: IMRT or VMAT
The IMRT or VMAT technique was used in our study.
Drug: Apatinib
Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE), Serious Adverse Event(SAE) Adverse events
Time Frame: Through study completion, an average of half a year]
Incidence of Treatment-Emergent Adverse Events
Through study completion, an average of half a year]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Through study completion, an average of 1 year
Objective Response Rate
Through study completion, an average of 1 year
PFS
Time Frame: 1year and 3years
Progression-Free Survival
1year and 3years
OS
Time Frame: 1year and 3years
overall survival
1year and 3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2018

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

September 2, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1210-CRT-ESC-IIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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