1. To evaluate the efficacy of neoadjuvant chemotherapy SLOG in localized pancreatic cancer 2. To evaluate the safety profile in patients with pancreatic cancer who receive neoadjuvant SLOG 3. To collect tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation
The role of neoadjuvant treatment in pancreatic adenocarcinoma is still under debate due to a relative lack of robust data compared with other gastrointestinal cancers. According to 2020 NCCN guidelines, neoadjuvant is now the accepted approach for borderline resectable (BR) disease, while upfront surgery is still the recommendation for resectable disease except in cases with high risk features. Another important advantage of treatment with neoadjuvant treatment is an increase in the proportion of patients who receive chemotherapy. Traditionally, only patients with a good performance status and a good recovery after surgery are treated with adjuvant chemotherapy. About 45% of patients do not receive adjuvant chemotherapy after resection due to poor performance status, postoperative morbidity, or early progression of disease. A small cohort study using total neoadjuvant FOLFIRINOX for borderline resectable pancreatic cancer yielded a promising result but the tolerability of FOLFIRINOX limited the use of this regimen in Asian population. In previous T1211 clinical trial, the SLOG regimen showed comparable efficacy with a better safety profile in metastatic pancreatic cancer. This phase II trial will evaluate the feasibility of SLOG regimen in patients with localized pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Gemcitabine 800 mg/m2 on day 1, oxaliplatin 85 mg/m2 on day 1, S-1 orally 80-120 mg/day \[depending on patient's body surface area (BSA)\] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA \< 1.25 m2: 80 mg/day * 1.25 m2 ≤ BSA \< 1.5 m2: 100 mg/day * BSA ≥ 1.5 m2: 120 mg/day
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
RECRUITINGNational Cheng-Kung University Hospital
Tainan, Taiwan
RECRUITINGNational Institute of Cancer Research
Tainan, Taiwan
RECRUITINGThe percentage of subjects with R0 resection after surgery
Time frame: 1 year
The percentage of subjects successfully underwent surgery after study drug treatment
Time frame: 1 year
The percentage of subjects with tumor shrinkage >30%
according to RECIST 1.1
Time frame: 1 year
The percentage of subjects without tumor progression
tumor progression is defined as increase of size by \>20% according to RECIST 1.1
Time frame: 1 year
Progression-free survival (PFS) of patient received study treatment
Time frame: 1 year
Overall survival (OS) of patient received study treatment
Time frame: 2 years
Duration of response (DOR) of patient received study treatment
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Biomarkers of treatment response by single cell RNA sequencing and whole exome sequencing
Biomarkers including but not limited to tumor mutation burden, change of immune cell proportion and percentage of T-reg in the tumor microenvironment.
Time frame: 4 years
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