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Gastric AdenocarcinomaPhase 1/2NCT05394740

Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy

A Phase 1/2 study testing Regorafenib, Nivolumab and CapeOX in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by National Cancer Center Hospital East 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

This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Regorafenib, Nivolumab and CapeOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteJapan
Study dates
6 Jun 2022to 25 Aug 2025
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed gastric/ gastroesophageal junction/esophageal adenocarcinoma that is confirmed to be unresectable/recurrent disease
  • At least 1 measurable lesion as defined by RECIST guideline version 1.1.
  • Age >= 20 years on the day informed consent is obtained
  • ECOG Performance status (PS) 0 or 1
  • The most recent laboratory value within 14 days prior to enrollment meets all of the following. (Examinations on the same day of the week 2 weeks prior to the day of enrollment may be utilized.) 1)Neutrophils >= 1,200/mm^3 2)Hemoglobin >= 8.0 g/dL 3)Platelets >= 75,000/mm^3 4)Total bilirubin <= 1.5 mg/dL 5)AST (GOT) <= 100 IU/L If liver metastases are present: <= 200 IU/L 6)ALT (GPT) <= 100 IU/L If liver metastases are present: <= 200 IU/L 7)Creatinine <= 1.5 mg/dL 8)Urine protein: any of the following (if any of the test criteria are met, other tests may not be performed.) (i)Urine protein (dipstick) <= 2+ (ii)Urine protein creatinine (UPC) ratio < 3.5 (iii)Urine protein <= 3,500 mg for 24-hour collection sample 9)PT-INR: <= 1.5 (<= 3.0 if on an anticoagulant)
  • No transfusions within 7 days prior to enrollment. (Transfusions on the same day of the week prior to enrollment are allowed)
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  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment. Both men and women must agree to use adequate contraception from the time of signing the informed consent form for a period of time (9 months in women and 7 months in men) after the last dose of protocol therapy
  • Oral administration is feasible
  • Written informed consent to participate in the study has been obtained from the patient themselves

Who cannot join

  • Prior chemotherapy for unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma (Note: Prior neoadjuvant or adjuvant therapy is allowed. However, treatment must have been completed at least 6 months prior to enrollment and progression must have occurred at least 6 months after the completion of the therapy)
  • HER2 positive (IHC3+, or IHC2+ and FISH positive)
  • Patients with hypertension that is difficult to control (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 90 mmHg) despite multiple antihypertensive medications
  • Patients with a history of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment
  • Patients with a history or evidence of congestive heart failure of Class III or higher according to the New York Heart Association (NYHA) classification
  • Confirmed metastases to the central nervous system (Confirmation by brain computed tomography scan or magnetic resonance imaging is required at screening only if metastases to the central nervous system are clinically suspected)
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  • Active double cancers with intensive treatments and possibly affect continuation of protocol treatment
  • Those with serious (needing inpatient care) complications (intestinal paralysis, intestinal obstruction, pulmonary fibrosis, poorly controlled diabetes mellitus, cardiac failure, myocardial infarction, angina pectoris, renal failure, hepatic failure, psychiatric disease, cerebrovascular disorder, ulcers requiring blood transfusions, etc.)
  • Those with active hepatitis
  • HBs antigen positive
  • HBs antibody or HBc antibody positive and HBV-DNA positive
  • Active hepatitis C (e.g., qualitative detection of HCV RNA) However, those who are HBs antigen positive may be considered eligible if HBV DNA is <1.3 log IU/mL (<2.1 log copies/mL) after treatment with antiviral drugs, such as nucleoside analogs.
  • Confirmed HIV infection
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease. Patients with type 1 diabetes mellitus, hypothyroidism which is manageable by hormone replacement, or skin disorders not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) are permitted to be enrolled.
  • Patients who require treatment with systemic corticosteroids (excluding temporary use for testing or prophylactic administration for allergic reactions, or for reduction of edema associated with radiotherapy), or immunosuppressants, or those treated with any of these therapies within 2 weeks prior to study enrollment
  • Patients who fail to use adequate contraception during the study participation and contraception period
  • Those unwilling or unable to comply with the protocol
  • Those considered by the principal investigator or sub-investigator as ineligible for this investigator-initiated trial

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

Official title: A Phase Ib/II Study of Regorafenib and Nivolumab Plus Chemotherapy in Patients With Unresectable Advanced/Recurrent Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma

This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma.

Read the detailed description

Phase Ib part: To evaluate safety and tolerability in combination of Regorafenib, Nivolumab and chemotherapy in patient with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma and to determine recommended dose in phase II part.

Phase II part: To evaluate safety and potential efficacy in combination of Regorafenib, Nivolumab and chemotherapy in patients in expanded arm.

The protocol treatment in this study is regorafenib and nivolumab plus CapeOX (Cohort A) / FOLFOX (Cohort B).

Regorafenib (the initial dose is 90 mg/dose) is orally administered daily for 21 days, followed by a 7-day washout period. Nivolumab is administered intravenously at a dose of 360 mg every 3 weeks (Cohort A) or 240 mg every 2 weeks (Cohort B).

Cohort A:CapeOX

  • Capecitabine 1,000 mg/m^2 administered orally, twice daily (Days 1 to 14 continuous dosing of CapeOX therapy)
  • Oxaliplatin 130 mg/m^2 administered intravenously (Day 1 of CapeOX therapy) *Repeat every 3 weeks as CapeOX therapy

Cohort B:FOLFOX

  • Leucovorin 400 mg/m^2 administered intravenously (Day 1 of FOLFOX therapy)
  • Fluorouracil 400 mg/m^2 administered intravenously (Day 1 of FOLFOX therapy) and 1,200 mg/m2 administered intravenously (Days 1 to 2 of FOLFOX therapy)
  • Oxaliplatin 85 mg/m^2 administered intravenously (Day 1 of FOLFOX therapy) *Repeat every 2 weeks as FOLFOX therapy
Being tested
Regorafenib, Nivolumab, CapeOX, FOLFOX regimen
Keywords
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Regorafenib, Nivolumab, CapeOX, FOLFOX
Medical subject headings
Adenocarcinoma Of Esophagus

What participants receive

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

  • RegorafenibDrug

    Also called Stivarga

    90 mg administered orally, once daily for 21 consecutive days followed by 7 days off

    *Repeat every 4 weeks as Regorafenib therapy

  • NivolumabDrug

    Also called Opdivo

    CohotA:360 mg administered intravenously, every 3 weeks *Administered on the same day as CapeOX therapy Cohort B: 240 mg administered intravenously, every 2 weeks *Administered on the same day as FOLFOX therapy

  • CapeOXDrug

    Also called XELOX, Capecitabine and Oxaliplatin

    For Cohort A only

    • Capecitabine 1,000 mg/m^2 administered orally, twice daily (Days 1 to 14 continuous dosing of CapeOX therapy)
    • Oxaliplatin 130 mg/m^2 administered intravenously (Day 1 of CapeOX therapy) *Repeat every 3 weeks as CapeOX therapy

  • FOLFOX regimenDrug

    Also called Leucovorin, Fluorouracil and Oxaliplatin

    For Cohort B only

    • Leucovorin 400 mg/m^2 administered intravenously (Day 1 of FOLFOX therapy)
    • Fluorouracil 400 mg/m^2 administered intravenously (Day 1 of FOLFOX therapy) and 1,200 mg/m2 administered intravenously (Days 1 to 2 of FOLFOX therapy)
    • Oxaliplatin 85 mg/m^2 administered intravenously (Day 1 of FOLFOX therapy) *Repeat every 2 weeks as FOLFOX therapy
Study groups in NCT05394740
Study groupRoleWhat they receive
Regorafenib, Nivolumab+CapeOX/FOLFOXExperimentalRegorafenib and Nivolumab+CapeOX (Cohort A) / Nivolumab+FOLFOX (Cohort B)
Receives: Drug: Regorafenib; Drug: Nivolumab; Drug: CapeOX; Drug: FOLFOX regimen

What is being measured

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

  1. Incidence of DLTs in Phase Ib part

    The incidence of DLTs in each cohort will be calculated for the DLT evaluable population.

    Measured: 4weeks

  2. ORR in Phase II part

    ORR is defined as the proportion of subjects whose best overall response based on the RECIST guideline version 1.1 is either CR or PR.

    Measured: 1 year

Secondary outcomes (5)

  1. PFS

    Progression-free survival is defined as the time from the enrollment date until the date when disease progression is determined or until the date of death from any cause, whichever comes earlier.

    Measured: 1 year

  2. DoR

    DoR is defined in responders as the period from the date of the first determination of overall response as CR or PR according to the RECIST guideline version 1.1 to the date of determination of progression (PD based on diagnostic imaging) or the date of death from any cause, whichever comes first.

    Measured: 1 year

  3. DCR

    DCR is defined as the proportion of patients in whom the best overall response was determined as CR or PR, or patients who maintained SD for 6 weeks or more according to the RECIST guideline version 1.1.

    Measured: 1 year

  4. OS

    The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause.

    Measured: 2 years

  5. Incidence of adverse events

    The treatment-emergent AEs will be summarized by CTCAE v5.0

    Measured: up to 30 days after the last dose

Timeline

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

  1. First posted27 May 2022
  2. Study start6 Jun 2022
  3. Primary completion14 Apr 2024
  4. Study completion25 Aug 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394740
Sponsor's protocol ID
EPOC2104
Status last verified
Apr 2026
First submitted
18 May 2022
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Regorafenib, Nivolumab and CapeOX in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by National Cancer Center Hospital East 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 9 inclusion and 18 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 9 Apr 2026. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of DLTs in Phase Ib part (time frame: 4weeks). The study lists 2 primary outcomes in all. 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 NCT05394740.

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 9 Apr 2026.

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