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A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914443
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Ono Pharmaceutical Co. Ltd
Fiverings Co., Ltd.
Information provided by (Responsible Party):
National Cancer Center, Japan

Brief Summary:
The main purpose of this study is to evaluate the safety of the neoadjuvant therapy, nivolumab with CF (5-FU, CDDP) or nivolumab with DCF (5-FU, CDDP, DTX), for locally advanced esophageal carcinoma.

Condition or disease Intervention/treatment Phase
Locally Advanced Esophageal Squamous Cell Carcinoma Biological: Nivolumab Drug: 5-FU Drug: CDDP Drug: DTX Phase 1

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Study Type : Interventional
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma FRONTiER Trial
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
Biological: Nivolumab
240 mg or 360 mg
Other Name: ONO-4538

Drug: 5-FU
750 or 800 mg^2
Other Name: 5-Fluorouracil

Drug: CDDP
70 or 80 mg/m^2
Other Name: Cisplatin

Experimental: Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
Biological: Nivolumab
240 mg or 360 mg
Other Name: ONO-4538

Drug: 5-FU
750 or 800 mg^2
Other Name: 5-Fluorouracil

Drug: CDDP
70 or 80 mg/m^2
Other Name: Cisplatin

Experimental: Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
Biological: Nivolumab
240 mg or 360 mg
Other Name: ONO-4538

Drug: 5-FU
750 or 800 mg^2
Other Name: 5-Fluorouracil

Drug: CDDP
70 or 80 mg/m^2
Other Name: Cisplatin

Drug: DTX
70 mg/m^2
Other Name: Docetaxel

Experimental: Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
Biological: Nivolumab
240 mg or 360 mg
Other Name: ONO-4538

Drug: 5-FU
750 or 800 mg^2
Other Name: 5-Fluorouracil

Drug: CDDP
70 or 80 mg/m^2
Other Name: Cisplatin

Drug: DTX
70 mg/m^2
Other Name: Docetaxel




Primary Outcome Measures :
  1. Rate of participants with dose limiting toxicities (DLTs) [ Time Frame: from initial dose to 30 post-operative days ]
    To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx


Secondary Outcome Measures :
  1. Response rate (RR): percentage of participants with with a best response of CR or PR [ Time Frame: from baseline to date of disease progression, approximately 24 months ]
    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

  2. Pathological complete response rate [ Time Frame: from baseline to operation, average of 10 weeks after initial dose ]
    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

  3. Radical resection rate [ Time Frame: at operation, average of 10 weeks after initial dose ]
    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

  4. Treatment completion rate [ Time Frame: from baseline to operation, average of 10 weeks after initial dose ]
    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

  5. Adverse event (AE) expression rate [ Time Frame: up to 30 postoperative days ]
    To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx

  6. Progression-free survival (PFS) [ Time Frame: from baseline to date of disease progression or death, approximately 24 month ]
    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

  7. Overall survival (OS) [ Time Frame: from baseline to date of death, approximately 24 month ]
    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenosquamous carcinoma or basal cell carcinoma
  2. All esophageal cancer lesions are localized in the thoracic esophagus
  3. Patients are classified as clinical stage T1N1-3M0 or T2-3N0-3M0 in the UICC-TNM classification 8th edition
  4. The age is over 20 years old and under 75 on the enrollment date
  5. PS 0-1
  6. With or without measurable lesions
  7. Patients who have no medical history of treatment for esophageal cancer
  8. Patients who have no medical history of chemotherapy, radiotherapy and endocrine therapy including treatment for other types of cancer
  9. The results of laboratory tests within 14 days before enrollment meet the inclusion criteria
  10. Esophageal cancer radical surgery (R0) by open-chest surgery (or thoracoscopic surgery) and laparotomy (or laparoscopic surgery) is judged possible
  11. Patients who have no complication or history of thyroid dysfunction
  12. Patients who have no complication or history of autoimmune disease
  13. Patients who don't have treatment with systemic corticostroids (dose of 10mg/day over in prednisolone equivalent) or imunosuppressants within 14 days before enrollment
  14. Patinets who have no complication or hisoty of pneumonitis or pulmonary fibrosis which had been diagnosed by imaging tests or phisical examination
  15. For females, who have agreed with contraception from start of investigational drug administration to 5 months after last dose of investigational drug. For males who have agreed with contraception from start of investigational drug administration to 7 months after last dose of investigational drug.
  16. Obtained the written informed consent from patients"

Exclusion criteria:

  1. Patients who have active multiple cancers
  2. Patients who have infectious disease which is active and need the systemic treatment
  3. Positive with HBs antigen, or HCV-RNA or anti HIV antibody, or anti HTLV-1 antibody tests
  4. Negative with HBs antigen test and positive with anti HBs antibody or anti HBc antibody tests, and positive with HBV-DNA quantitative test
  5. Pregnant, suspected pregnant or lactating
  6. Patients who have Psycosis or psychiatric symptoms are judged inappropriate for paticipation of the trial
  7. Patients who need the treatment with continued use of flucytosine, phenytoin or warfalin pottasium
  8. Ptients who have a medical history of allergy to iodine
  9. Patients who have hypersensitivity to docetaxel, cisplatin, and drug containing polysorbate 80
  10. Patients who have a complication or a history of highly sensitive reactions to antibody formulations
  11. Even if insulin or oral hypoglycemic agent is continued to use, the result of HbA1c test is 6.5% or more in JDS or 6.9% or more in NGSP
  12. Patients who have advanced pulmonary emphysema which is observed by pulmonary function test or CT test
  13. Patients who have uncontrollable hypertension
  14. Patients who have unstable angina or a medical history of myocardial infarction within 6 months before for enrollment
  15. Patients who have diverticulitis or symptomatic peptic ulcer disease
  16. Patients who have history of transplantation therapy such as hematopoietic stem cell transplantation
  17. Patients who have medical history of treatment with anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CD137 antibody, anti CTLA-4 antibody or any other antibody for inhibition or modulation of T cell costimulatory pathway or cancer vaccine"

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): NCT03914443


Contacts
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Contact: Tatsushi Goto +81-6-6358-7004 gotou@fiverings.co.jp

Locations
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Japan
National Cancer Center Hospital Recruiting
Tokyo, Japan
Contact: Ken Kato, M.D./Ph.D         
Sponsors and Collaborators
National Cancer Center, Japan
Ono Pharmaceutical Co. Ltd
Fiverings Co., Ltd.
Investigators
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Study Chair: Ken Kato, MD/PhD Department of Gastrointestinal Medical Oncology, National cancer center hospital

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Responsible Party: National Cancer Center, Japan
ClinicalTrials.gov Identifier: NCT03914443    
Other Study ID Numbers: JCOG1804E
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Center, Japan:
Esophageal squamous cell carcinoma
Neoadjuvant chemotherapy
Nivolumab
JCOG
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nivolumab
Antineoplastic Agents
Antineoplastic Agents, Immunological