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Neoadjuvant gemcitabine plus nab-paclitaxel vs gemcitabine plus S-1 for geriatric pancreatic cancerTrial tests two chemo combos for older pancreatic cancer patients

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Key Takeaway
Note that results are not yet available as the trial is currently in progress.

This Phase III randomized controlled trial was designed to evaluate the efficacy of neoadjuvant gemcitabine plus nab-paclitaxel (GnP) compared to neoadjuvant gemcitabine plus S-1 (GS) in a population of 400 geriatric patients with resectable pancreatic cancer. The study is being conducted across 28 institutions.

The primary outcome measure is overall survival. Secondary outcomes were not reported. Because the trial was initiated in October 2022 and is currently ongoing, no main results regarding survival or other endpoints have been reported yet.

Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, are not reported at this time. The study's primary limitation is that it is still in progress, meaning the trial has not reached a point where conclusions can be drawn regarding the superiority or non-inferiority of GnP over GS.

Clinical application of these findings is currently restricted as results are pending. The study aims to determine if neoadjuvant GnP offers a survival advantage over GS for this specific geriatric population.

How this fits prior evidence

How this fits prior evidence: This trial addresses a gap in the management of pancreatic cancer by specifically evaluating neoadjuvant regimens for geriatric patients. While previous coverage noted that ProCore FNB provides diagnostic yield comparable to standard FNA for pancreatic mass lesions, this study focuses on the systemic treatment and survival outcomes following resection.

A new clinical trial is testing which chemotherapy combination works best for older adults with pancreatic cancer that can be surgically removed. The study, called a Phase III randomized controlled trial, is taking place at 28 institutions and includes 400 geriatric patients. Researchers are comparing two neoadjuvant (pre-surgery) treatments: gemcitabine plus nab-paclitaxel (GnP) versus gemcitabine plus S-1 (GS). The main goal is to see which combination leads to longer overall survival.

The trial started in October 2022 and is still ongoing. Because the study is not yet complete, no results are available. This means we do not yet know if one treatment is better than the other, or what side effects patients might experience. The researchers have not reported any safety information, such as adverse events or how well patients tolerated the treatments.

It is important to understand that this is an early-stage investigation. The findings will not be known until the trial finishes and the data are analyzed. For now, this study represents a step toward finding better treatments for older patients with pancreatic cancer, but it does not change current medical practice. Patients should discuss their treatment options with their doctor.

What this means for you:
This ongoing trial may help guide treatment for older adults with pancreatic cancer, but results are not yet available.

Common questions

What is this trial studying?

This trial compares two chemotherapy combinations given before surgery for older adults with pancreatic cancer that can be removed. The combinations are gemcitabine plus nab-paclitaxel versus gemcitabine plus S-1.

Who can participate in this trial?

The trial includes geriatric patients with resectable pancreatic cancer. It is being conducted at 28 institutions and aims to enroll 400 participants.

Are the results of this trial available?

No, the trial started in October 2022 and is still ongoing. No results have been reported yet, including survival data or side effects.

How is this trial different from current treatments?

This trial specifically focuses on older patients with resectable pancreatic cancer, comparing two neoadjuvant chemotherapy regimens. Current practice varies, and this study aims to determine which combination may offer better survival.

Study Details

Study typeRct
Sample sizen = 400
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
Neoadjuvant gemcitabine plus S-1 (GS) followed by surgery and adjuvant S-1 is the standard of care for resectable pancreatic cancer. Since ~73% of newly diagnosed pancreatic cancer patients are aged ≥70, effective treatments are strongly needed in this geriatric population. In unresectable pancreatic cancer, gemcitabine plus nab-paclitaxel (GnP) is widely used, even among geriatric patients. To evaluate the survival advantage of neoadjuvant GnP over GS for geriatric patients with resectable pancreatic cancer, an open-label randomized phase III trial (JCOG2101C) has been initiated since October 2022. A total of 400 patients will be enrolled from 28 institutions within 3 years. The primary endpoint is overall survival. This trial was registered at the Japan Registry of Clinical Trials as jRCTs031220351 [https://jrct.mhlw.go.jp/latest-detail/jRCTs031220351].
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