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

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ClinicalTrials.gov Identifier: NCT03200691
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 7, 2017
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Shixiu Wu, Hangzhou Cancer Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Esophageal Diseases Radiation: 3-DCRT or IMRT radiation Drug: anti-PD-1 antibody SHR-1210 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma
Anticipated Study Start Date : August 10, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nimotuzumab with radiotherapy

Patients 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.

Radiation: 3-DCRT or IMRT radiation
Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40 Gy/20f.
Drug: anti-PD-1 antibody SHR-1210
SHR-1210 (200mg fixed dose every 2 weeks for 2 cycles) will be administered as an intravenous infusion over 60 minutes.

Primary Outcome Measures :
  1. Pathologic Complete Response Rate [ Time Frame: 2-4 weeks after completion of radiotherapy ]
    the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery

Secondary Outcome Measures :
  1. Disease-Free Survival [ Time Frame: 2 years ]
    Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.

  2. Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria. [ Time Frame: 6 months ]
    From the date of randomization to 6 months after esophagectomy. An expected average of 6 months

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.
  2. With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage Ⅱa-Ⅲ.
  3. age:18-75 years, male or female.
  4. Can provide either a newly obtained or archival tumor tissue sample.
  5. ECOG 0-1.
  6. Life expectancy of greater than 12 weeks.
  7. Without serious system dysfunction and could tolerate radiotherapy.
  8. 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.
  9. Patients must have normal electrocardiogram results and no history of congestive heart failure.
  10. Women of childbearing age should voluntarily take contraceptive measures.
  11. Without drug addition
  12. Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events
  13. Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.

Exclusion Criteria:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  2. With unresectable disease including any T4b or M1 disease
  3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  4. 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.
  5. Known central nervous system (CNS) metastases.
  6. Subjects with any active autoimmune disease or history of autoimmune disease.
  7. 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;
  8. 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);
  9. History of Interstitial Pneumonia or active non-infectious pneumonitis.
  10. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
  11. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
  12. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.
  13. 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.
  14. Received a live vaccine within 4 weeks of the first dose of study medication.
  15. Pregnancy or breast feeding.
  16. Decision of unsuitableness by principal investigator or physician-in-charge.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200691

Contact: shixiu wu, MD +8657186826086 wushixiu@medmail.com.cn

China, Zhejiang
Hangzhou Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310002
Contact: Shixiu Wu, MD    +8657186826086    wushixiu@medmail.com.cn   
Sponsors and Collaborators
Hangzhou Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Shixiu Wu, Professor, Hangzhou Cancer Hospital
ClinicalTrials.gov Identifier: NCT03200691     History of Changes
Other Study ID Numbers: HangzhouCH09
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shixiu Wu, Hangzhou Cancer Hospital:
Esophageal Squamous Cell Carcinoma
Neoadjuvant treatment

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Immunologic Factors
Physiological Effects of Drugs