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

NCT ID: NCT03200691

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2020-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3-DCRT or IMRT radiation

Intervention Type: RADIATION

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

anti-PD-1 antibody SHR-1210

Intervention Type: DRUG

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

Interventions

3-DCRT or IMRT radiation

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hangzhou Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shixiu Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

shixiu wu, MD

Role: CONTACT

wushixiu@medmail.com.cn

+8657186826086

Facility Contacts

Shixiu Wu, MD

Role: primary

wushixiu@medmail.com.cn

+8657186826086

Other Identifiers

HangzhouCH09

Identifier Type: -

Identifier Source: org_study_id