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Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy

NCT05394740 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Adenocarcinoma

Interventions

DRUG

Regorafenib

90 mg administered orally, once daily for 21 consecutive days followed by 7 days off \*Repeat every 4 weeks as Regorafenib therapy

DRUG

Nivolumab

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

DRUG

CapeOX

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

DRUG

FOLFOX regimen

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

Sponsors & Collaborators

  • Bayer Yakuhin, Ltd.

    collaborator INDUSTRY

  • National Cancer Center Hospital East

    lead OTHER

Principal Investigators

  • Kohei Shitara, MD · National Cancer Center Hospital East

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2024-04-14
Completion
2025-08-25

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394740 on ClinicalTrials.gov