An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients With Gastric Cancer

Sponsor
National Cancer Center Hospital East
Study ID
NCT04745988
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Lenvatinib 20mg — DRUG
    Lenvatinib will be administered at a dose of 20mg as oral dose, once a day.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
  • Lenvatinib 8mg — DRUG
    Lenvatinib will be administered at a dose of 8mg as oral dose, once a day.
  • Docetaxel — DRUG
    Docetaxel will be administered at a dose of 50mg/m\^2 as a IV infusion, Q2W.
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered at a dose of 85mg/m\^2 as a IV infusion, Q2W.
  • Levofolinate — DRUG
    Levofolinate will be administered at a dose of 200mg/m\^2 as a IV infusion, Q2W.
  • Fluorouracil — DRUG
    Levofolinate will be administered at a dose of 2600mg/m\^2 as a IV infusion, Q2W.

Study Details

This study is an open label phase 2 study to evaluate the safety and efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the neoadjuvant / adjuvant treatment for Patients with Gastric Cancer.

Key Dates

First listed
Feb 9, 2021
Start date
Nov 11, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib Plus Pembrolizumab
    One cycle is 21 days, with Lenvatinib plus Pembrolizumab repeated 3 cycles before surgery and 3 cycles after surgery, followed by 11 cycles of pembrolizumab monotherapy as the adjuvant treatment.
  • Experimental: Lenvatinib, Pembrolizumab Plus FLOT
    One cycle is 21 days, with Lenvatinib, Pembrolizumab plus FLOT repeated 3 cycles before surgery and 3 cycles after surgery, followed by 11 cycles of pembrolizumab monotherapy as the adjuvant treatment.

Primary Outcome Measure

Major pathological response (MPR) rate [ Time Frame: 6 months ]

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