NCT03222440

Brief Summary

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal 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 in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 19, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

July 13, 2017

Last Update Submit

December 2, 2019

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Adverse events (AE), Serious Adverse Event(SAE)

    Through study completion, an average of half a year

Secondary Outcomes (3)

  • ORR

    Through study completion, an average of 1 year

  • PFS

    1year and 3years

  • OS

    1year and 3years

Study Arms (1)

SHR-1210+ Radiotherapy

EXPERIMENTAL

Radiotherapy,intensity modulated radiation therapy (IMRT), 54-60 Gy, 1.8-2.0 Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the 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.

Drug: SHR-1210

Interventions

SHR-1210DRUG

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Also known as: Anti-PD-1 Antibody
SHR-1210+ Radiotherapy

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 femal.
  • 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.
  • Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • ECOG 0-1.
  • Adequate organ function.
  • Life expectancy of greater than 6 months.
  • Patient has given written informed consent.

You may not qualify if:

  • Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  • Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
  • Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  • 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 during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
  • Received a live vaccine within 4 weeks of the first dose of study medication.
  • Pregnancy or breast feeding.
  • Decision of unsuitableness by principal investigator or physician-in-charge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Related Publications (1)

  • Wei H, Li Y, Guo Z, Ma X, Li Y, Wei X, Han D, Zhang T, Chen X, Yan C, Zhou J, Pang Q, Wang P, Zhang W. Comparison of dynamic changes in the peripheral CD8+ T cells function and differentiation in ESCC patients treated with radiotherapy combined with anti-PD-1 antibody or concurrent chemoradiotherapy. Front Immunol. 2022 Nov 21;13:1060695. doi: 10.3389/fimmu.2022.1060695. eCollection 2022.

    PMID: 36479110DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumabspartalizumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • PING WANG, MD.PHD

    Tianjin Medical University Institute and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 19, 2017

Study Start

July 19, 2017

Primary Completion

July 20, 2018

Study Completion

November 1, 2019

Last Updated

December 4, 2019

Record last verified: 2019-11

Locations

CN(1)