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ACTIVE NOT RECRUITING
NCT04745988
PHASE2

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

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2021-11-11

Completion Date

2027-08

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Lenvatinib 20mg

Lenvatinib will be administered at a dose of 20mg as oral dose, once a day.

DRUG

Pembrolizumab

Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).

DRUG

Lenvatinib 8mg

Lenvatinib will be administered at a dose of 8mg as oral dose, once a day.

DRUG

Docetaxel

Docetaxel will be administered at a dose of 50mg/m\^2 as a IV infusion, Q2W.

DRUG

Oxaliplatin

Oxaliplatin will be administered at a dose of 85mg/m\^2 as a IV infusion, Q2W.

DRUG

Levofolinate

Levofolinate will be administered at a dose of 200mg/m\^2 as a IV infusion, Q2W.

DRUG

Fluorouracil

Levofolinate will be administered at a dose of 2600mg/m\^2 as a IV infusion, Q2W.

Locations (1)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan