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Locally Advanced Esophageal Squamous Cell CarcinomaPhase 1NCT03914443

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

A Phase 1 study testing Nivolumab, 5-FU and CDDP in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by National Cancer Center, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Nivolumab, 5-FU and CDDP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteJapan
Study dates
7 May 2019to 31 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients who have active multiple cancers
  • Patients who have an infectious disease that is active and need the systemic treatment
  • Positive with HBs antigen, HCV-RNA or anti-HIV antibody, or anti-HTLV-1 antibody tests
  • Negative with HBs antigen test and positive with anti HBs antibody or anti HBc antibody tests, and positive with HBV-DNA quantitative test
  • Pregnant, suspected pregnant, or lactating
  • Patients who have Psycosis or psychiatric symptoms are judged inappropriate for participation in the trial
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  • Patients who need the treatment with continued use of flucytosine, phenytoin, or warfarin potassium
  • Patients who have a medical history of allergy to iodine
  • Patients who have hypersensitivity to docetaxel, cisplatin, and drug-containing polysorbate 80
  • Patients who have a complication or a history of highly sensitive reactions to antibody formulations
  • Even if insulin or oral hypoglycemic agent is continued use, the result of HbA1c test is 6.5% or more in JDS or 6.9% or more in NGSP
  • Patients who have advanced pulmonary emphysema, which is observed by pulmonary function test or CT test
  • Patients who have uncontrollable hypertension
  • Patients who have unstable angina or a medical history of myocardial infarction within 6 months before enrollment
  • Patients who have diverticulitis or symptomatic peptic ulcer disease
  • Patients who have a history of transplantation therapy, such as hematopoietic stem cell transplantation
  • Patients who have a medical history of treatment with an 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."

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital

    Tokyo

Other trials in Japan

About this study

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

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.

Being tested
Nivolumab, 5-FU, CDDP, DTX
Keywords
Esophageal squamous cell carcinoma, Neoadjuvant chemotherapy, Nivolumab, JCOG
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called ONO-4538

    240 mg or 360 mg

  • 5-FUDrug

    Also called 5-Fluorouracil

    750 or 800 mg^2

  • CDDPDrug

    Also called Cisplatin

    70 or 80 mg/m^2

  • DTXDrug

    Also called Docetaxel

    70 mg/m^2

Study groups in NCT03914443
Study groupRoleWhat they receive
Cohort AExperimental"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
Receives: Biological: Nivolumab; Drug: 5-FU; Drug: CDDP
Cohort BExperimental"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 "
Receives: Biological: Nivolumab; Drug: 5-FU; Drug: CDDP
Cohort CExperimental"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"
Receives: Biological: Nivolumab; Drug: 5-FU; Drug: CDDP; Drug: DTX
Cohort DExperimental"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"
Receives: Biological: Nivolumab; Drug: 5-FU; Drug: CDDP; Drug: DTX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of participants with dose limiting toxicities (DLTs)

    To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: from initial dose to 30 post-operative days

Secondary outcomes (7)

  1. Response rate (RR): percentage of participants with with a best response of CR or PR

    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: from baseline to date of disease progression, approximately 24 months

  2. Pathological complete response rate

    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: from baseline to operation, average of 10 weeks after initial dose

  3. Radical resection rate

    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: at operation, average of 10 weeks after initial dose

  4. Treatment completion rate

    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: from baseline to operation, average of 10 weeks after initial dose

  5. Adverse event (AE) expression rate

    To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: up to 30 postoperative days

  6. Progression-free survival (PFS)

    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: from baseline to date of disease progression or death, approximately 24 month

  7. Overall survival (OS)

    To evaluate the efficacy of combination chemotherapy with nivolumab as neoadjuvant Tx

    Measured: from baseline to date of death, approximately 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start7 May 2019
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03914443
Sponsor's protocol ID
JCOG1804E
Status last verified
May 2025
First submitted
11 Apr 2019
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yamamoto S, Kato K, Daiko H, Kojima T, Hara H, Abe T, Tsubosa Y, Nagashima K, Aoki K, Mizoguchi Y, Kitano S, Yachida S, Shiba S, Kitagawa Y. Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E). Future Oncol. 2020 Jul;16(19):1351-1357. doi: 10.2217/fon-2020-0189. Epub 2020 May 12.

    PubMed 32396014

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab, 5-FU and CDDP in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by National Cancer Center, Japan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of participants with dose limiting toxicities (DLTs) (time frame: from initial dose to 30 post-operative days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03914443, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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