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

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Japan
• Collaborators: Fiverings Co., Ltd.; Ono Pharmaceutical Co. Ltd
• Treatments: Cisplatin; Docetaxel; Fluorouracil; Nivolumab

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"