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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.

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.

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

Lenvatinib 20mg

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

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

Lenvatinib 8mg

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

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

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

Levofolinate

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

Akihito Kawazoe, MD

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.

This study is an open-label, single-arm, single-center, phase 2 clinical trial. Eligible patients are with previously untreated gastric and gastroesophageal junction adenocarcinoma as defined by cT2-4 and/or cN+ without evidence of metastatic disease. Patients in the exploratory cohort will receive 3 cycles of 20 mg oral Lenvatinib daily plus 200 mg intravenous Pembrolizumab every 3 weeks as the neoadjuvant treatment followed by surgery, and then 3 cycles of Lenvatinib plus Pembrolizumab followed by 11 cycles of Pembrolizumab monotherapy as the adjuvant treatment. Also, Patients in the FLOT cohort will receive 3 cycles of 8 mg oral Lenvatinib daily, 200 mg intravenous Pembrolizumab every 3 weeks and FLOT (Docetaxel 50 mg/m2, Oxaloplatin 85 mg/m2, Levofolinate 200 mg/m2, 5-FU 2600 mg/m2) every 2 weeks as the neoadjuvant treatment followed by surgery, and then 3 cycles of Lenvatinib ,Pembrolizumab plus FLOT followed by 11 cycles of Pembrolizumab monotherapy as the adjuvant treatment.

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

The MPR rate will be defined as the proportion of patients whose percentage of residual tumor in the stomach and lymph node decreased to \< 10%, as determined by a pathologist.

The pCR rate will be defined as the proportion of patients whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.

The number of patients achieving endoscopic CR, PR, SD, or PD will be separately tabulated.

The radical resection rate will be defined as the proportion of patients who underwent a radical resection (R0 resection).

The treatment completion rate will be defined as the proportion of patients who started the protocol treatment, completed a three-cycle treatment with the study drug, and then underwent a radical resection (R0 resection).

The treatment completion rate will be defined as the proportion of patients who started the protocol treatment, completed a three-cycle treatment with the study drug, and then underwent a radical resection (R0 resection) and adjuvant treatment was performed up to 14 cycles.

The registration date is the starting date, and is defined as the period until the event that occurs any of the following.

* Disease progression based on image evaluation using RECIST 1.1
* Recurrence based on CT or biopsy among patients with no postoperative lesions
* Death of any cause If it is determined to be exacerbated based on the image evaluation, the inspection date on which the image inspection was performed shall be the exacerbation date.

Secondary primary malignancies are not an EFS event. Patients for whom no EFS event has been recorded will be censored on the final image evaluation date.

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

Surviving patients should be censored on the last day of PFS confirmed (Confirmation of survival by telephone inquiry will be acceptable. However, the fact of confirming survival should be documented in medical records.).

Patients who are lost to follow up should be censored on the last day when their survival is confirmed before being lost to follow up.

For adverse events due to protocol treatment, determine the frequency of worst grades in all courses according to CTCAE v5.0, the incidence of adverse events of Grade 3 or higher, and the incidence of adverse events of Grade 4 or higher.

Spots Global Cancer Trial Database for lenvatinib 8mg