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Esophageal NeoplasmsPhase 2NCT03200691

Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma

A Phase 2 study testing 3-DCRT or IMRT radiation and anti-PD-1 antibody SHR-1210 in people with Esophageal Neoplasms and Esophageal Diseases, run by Hangzhou Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 followed by surgery in treating patients with resectable esophageal squamous cell carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Neoplasms, Esophageal Diseases
What is being tested?
3-DCRT or IMRT radiation and anti-PD-1 antibody SHR-1210
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteChina
Study dates
10 Aug 2017to 1 Jul 2020
Phase
Phase 2
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

  • Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.
  • With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage Ⅱa-Ⅲ.
  • age:18-75 years, male or female.
  • Can provide either a newly obtained or archival tumor tissue sample.
  • ECOG 0-1.
  • Life expectancy of greater than 12 weeks.
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  • Without serious system dysfunction and could tolerate radiotherapy.
  • Patients must have normal marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.5 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
  • Patients must have normal electrocardiogram results and no history of congestive heart failure.
  • Women of childbearing age should voluntarily take contraceptive measures.
  • Without drug addition
  • Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events
  • Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.

Who cannot join

  • Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  • With unresectable disease including any T4b or M1 disease
  • Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  • Other malignancy within 5 years prior to entry into the study, expect for 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.
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  • 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);
  • History of Interstitial Pneumonia or active non-infectious pneumonitis.
  • Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
  • 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.
  • 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 orequivalent for replacement therapy.
  • 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.

Trial locations and contacts

1 site in 1 country.

shixiu wu, MD contact

+8657186826086

wushixiu@medmail.com.cn

China1 site, 1 recruiting

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang, 310002

    Shixiu Wu, MD, +8657186826086, wushixiu@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma

The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 followed by surgery in treating patients with resectable esophageal squamous cell carcinoma

Being tested
3-DCRT or IMRT radiation, anti-PD-1 antibody SHR-1210
Keywords
Esophageal Squamous Cell Carcinoma, PD-1, Neoadjuvant treatment
Medical subject headings
Esophageal Neoplasms, Esophageal Diseases, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • 3-DCRT or IMRT radiationRadiation

    Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40 Gy/20f.

  • anti-PD-1 antibody SHR-1210Drug

    SHR-1210 (200mg fixed dose every 2 weeks for 2 cycles) will be administered as an intravenous infusion over 60 minutes.

Study groups in NCT03200691
Study groupRoleWhat they receive
Nimotuzumab with radiotherapyExperimentalPatients will receive neoadjuvant radiotherapy with concurrent anti-PD-1 antibody SHR-1210. Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40Gy/20f. SHR-1210 200mg fixed dose every 2 weeks delivered concurrent with radiation therapy. After 2-4 weeks of neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease.
Receives: Radiation: 3-DCRT or IMRT radiation; Drug: anti-PD-1 antibody SHR-1210

What is being measured

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

  1. Pathologic Complete Response Rate

    the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery

    Measured: 2-4 weeks after completion of radiotherapy

Secondary outcomes (2)

  1. Disease-Free Survival

    Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.

    Measured: 2 years

  2. Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria.

    From the date of randomization to 6 months after esophagectomy. An expected average of 6 months

    Measured: 6 months

Timeline

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

  1. First posted27 Jun 2017
  2. Study start10 Aug 2017 (estimated)
  3. Primary completion30 Jun 2018 (estimated)
  4. Study completion1 Jul 2020 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03200691
Sponsor's protocol ID
HangzhouCH09
Status last verified
Aug 2017
First submitted
22 Jun 2017
Last updated
7 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3-DCRT or IMRT radiation and anti-PD-1 antibody SHR-1210 in people with Esophageal Neoplasms and Esophageal Diseases, run by Hangzhou Cancer 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 13 inclusion and 16 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 7 Aug 2017. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact shixiu wu, MD (+8657186826086, wushixiu@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response Rate (time frame: 2-4 weeks after completion of radiotherapy). 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 NCT03200691.

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 7 Aug 2017.

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