Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy

Sponsor
National Cancer Center Hospital East
Study ID
NCT05394740
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Regorafenib — DRUG
    90 mg administered orally, once daily for 21 consecutive days followed by 7 days off \*Repeat every 4 weeks as Regorafenib therapy
  • Nivolumab — DRUG
    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
  • CapeOX — DRUG
    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 regimen — DRUG
    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 Details

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.

Key Dates

Start date
Jun 6, 2022
Status verified
Apr 2026
Primary completion
Apr 14, 2024
Completion
Aug 25, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regorafenib, Nivolumab+CapeOX/FOLFOX
    Regorafenib and Nivolumab+CapeOX (Cohort A) / Nivolumab+FOLFOX (Cohort B)

Primary Outcome Measure

Incidence of DLTs in Phase Ib part [ Time Frame: 4weeks ]

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