An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in the Neoadjuvant / Adjuvant Treatment for Patients With Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT04745988|
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : November 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Lenvatinib Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in the Neoadjuvant / Adjuvant Treatment for Patients With Gastric Cancer|
|Actual Study Start Date :||November 11, 2021|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2026|
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.
Lenvatinib will be administered at a dose of 20mg as oral dose, once a day.
Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
- Major pathological response (MPR) rate [ Time Frame: 6 months ]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.
- Pathological complete response (pCR) rate [ Time Frame: 6 months ]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.
- Tumor response in the gastric primary lesion [ Time Frame: 6 months ]The number of patients achieving endoscopic CR, PR, SD, or PD will be separately tabulated.
- Radical resection rate [ Time Frame: 6 months ]The radical resection rate will be defined as the proportion of patients who underwent a radical resection (R0 resection).
- Treatment completion rate until surgery [ Time Frame: 6 months ]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).
- Treatment completion rate until adjuvant treatment [ Time Frame: 1 year 8 months ]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.
- Event free survival (EFS) [ Time Frame: 3 years ]
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.
- Overall survival (OS) [ Time Frame: 3 years ]
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.
- The incidence of adverse events [ Time Frame: Up to 30 days after the last dose ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745988
|Contact: Akihito Kawazoe, MD||+81-4-7133-1111||LenvaPem_core@east.ncc.go.jp|
|National Cancer Center Hospital East||Recruiting|
|Kashiwa, Chiba, Japan|
|Contact: Akihito Kawazoe, MD +81-4-7133-1111 LenvaPem_core@east.ncc.go.jp|
|Principal Investigator: Akihito Kawazoe, MD|