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

NCT03200691 | Unknown Phase 2 DMC

• 1 other identifier: HangzhouCH09
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Neoplasms; Esophageal Diseases

Keywords

Esophageal Squamous Cell Carcinoma; PD-1; Neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate

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

  2-4 weeks after completion of radiotherapy

Secondary Outcomes (2)

• Disease-Free Survival

  2 years

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

  6 months

Study Arms (1)

Nimotuzumab with radiotherapy

EXPERIMENTAL

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; Drug: anti-PD-1 antibody SHR-1210

Interventions

3-DCRT or IMRT radiation RADIATION

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

Nimotuzumab with radiotherapy

anti-PD-1 antibody SHR-1210 DRUG

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

Nimotuzumab with radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hangzhou Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310002, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Diseases; Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Central Study Contacts

shixiu wu, MD

CONTACT

+8657186826086; wushixiu@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: August 10, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 1, 2020
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)