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Esophageal CancerNCT03671265

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

A study testing SHR-1210, IMRT or VMAT and Apatinib in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
SHR-1210, IMRT or VMAT and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
17 Sep 2018to 1 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Ping Wang, M. D., 08623340123-1121, wangping@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: 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。

Being tested
SHR-1210, IMRT or VMAT, Apatinib
Keywords
Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, SHR-1210, Apatinib
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    Also called Anti-PD-1 Antibody

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

  • IMRT or VMATRadiation

    The IMRT or VMAT technique was used in our study.

  • ApatinibDrug

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

Study groups in NCT03671265
Study groupRoleWhat they receive
SHR-1210 + Chemotherapy + RadiotherapyExperimentalRadiotherapy(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 )
Receives: Drug: SHR-1210; Radiation: IMRT or VMAT; Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence of Treatment-Emergent Adverse Events

    Measured: Through study completion, an average of half a year]

Secondary outcomes (3)

  1. ORR

    Objective Response Rate

    Measured: Through study completion, an average of 1 year

  2. PFS

    Progression-Free Survival

    Measured: 1year and 3years

  3. OS

    overall survival

    Measured: 1year and 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start17 Sep 2018
  3. Primary completion1 Sep 2019 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671265
Sponsor's protocol ID
SHR-1210-CRT-ESC-IIT
Status last verified
Aug 2018
First submitted
2 Sep 2018
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37275884

  • 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.

    PubMed 35046943

  • 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.

    PubMed 34616588

Questions about this trial

What is this clinical trial studying?

A study testing SHR-1210, IMRT or VMAT and Apatinib in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AE), Serious Adverse Event(SAE) Adverse events (time frame: Through study completion, an average of half a year]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671265, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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