NCT03671265

Brief Summary

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。

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 9, 2019

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

September 2, 2018

Last Update Submit

January 7, 2019

Conditions

Esophageal Cancer

Keywords

Esophageal CancerConcurrent chemoradiationImmunotherapySHR-1210Apatinib

Outcome Measures

Primary Outcomes (1)

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

    Incidence of Treatment-Emergent Adverse Events

    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 + Chemotherapy + Radiotherapy

EXPERIMENTAL

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-1210Radiation: IMRT or VMATDrug: Apatinib

Interventions

SHR-1210DRUG

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

Also known as: Anti-PD-1 Antibody
SHR-1210 + Chemotherapy + Radiotherapy
IMRT or VMATRADIATION

The IMRT or VMAT technique was used in our study.

SHR-1210 + Chemotherapy + Radiotherapy
ApatinibDRUG

Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.

SHR-1210 + Chemotherapy + 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 female.
  • 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
  • \- Page 4 of 4 \[DRAFT\] -
  • 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-incharge.

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

RECRUITING

Related Publications (3)

  • Yan C, Huang H, Zheng Z, Ma X, Zhao G, Zhang T, Chen X, Cao F, Wei H, Dong J, Tang P, Jiang H, Wang M, Wang P, Pang Q, Zhang W. Spatial distribution of tumor-infiltrating T cells indicated immune response status under chemoradiotherapy plus PD-1 blockade in esophageal cancer. Front Immunol. 2023 May 19;14:1138054. doi: 10.3389/fimmu.2023.1138054. eCollection 2023.

    PMID: 37275884DERIVED

  • Ma X, Guo Z, Wei X, Zhao G, Han D, Zhang T, Chen X, Cao F, Dong J, Zhao L, Yuan Z, Wang P, Pang Q, Yan C, Zhang W. Spatial Distribution and Predictive Significance of Dendritic Cells and Macrophages in Esophageal Cancer Treated With Combined Chemoradiotherapy and PD-1 Blockade. Front Immunol. 2022 Jan 3;12:786429. doi: 10.3389/fimmu.2021.786429. eCollection 2021.

    PMID: 35046943DERIVED

  • Zhang W, Yan C, Zhang T, Chen X, Dong J, Zhao J, Han D, Wang J, Zhao G, Cao F, Zhou D, Jiang H, Tang P, Zhao L, Yuan Z, Wang Q, Wang P, Pang Q. Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study. Oncoimmunology. 2021 Sep 28;10(1):1971418. doi: 10.1080/2162402X.2021.1971418. eCollection 2021.

    PMID: 34616588DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumabspartalizumabRadiotherapy, Intensity-Modulatedapatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

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

September 2, 2018

First Posted

September 14, 2018

Study Start

September 17, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2021

Last Updated

January 9, 2019

Record last verified: 2018-08

Locations

CN(1)