Trial Evaluates Gemcitabine, S-1, and Radiation for Advanced Pancreatic Cancer
A Phase 2 clinical trial reports survival and surgical resection outcomes for patients receiving the GSRT protocol.
Key takeaways
- A Phase 2 trial evaluated the GSRT protocol, combining full-dose gemcitabine, S-1, and radiation for locally advanced pancreatic cancer.
- Among the 39 treated patients, the 1-year survival rate was 64.1% and the median overall survival was 16.6 months.
- Twelve patients underwent radical resection, achieving a 91.7% 1-year survival rate and a median overall survival of 44.3 months.
- The treatment was well tolerated, with 95% of patients successfully completing the chemoradiotherapy regimen.
A prospective clinical trial conducted in Japan has evaluated a concurrent chemotherapy and radiation protocol for patients with locally advanced pancreatic ductal adenocarcinoma.
The multicenter Phase 2 study, known as CSGO-HBP-008, investigated the safety and efficacy of combining full-dose gemcitabine and S-1 with concurrent radiation therapy—a regimen abbreviated as GSRT. The research enrolled 40 patients with locally advanced pancreatic cancer based on imaging findings across three high-volume centers in Japan between April 2013 and December 2018.
What Happened
Of the 40 enrolled patients, 39 received the GSRT protocol, which combined full-dose gemcitabine and S-1 chemotherapy concurrently with 50.4 Gy of radiation therapy. Following chemoradiotherapy, clinicians reevaluated the patients for surgical eligibility. Patients with tumors deemed resectable underwent surgical resection. For patients with unresectable tumors, chemotherapy was continued for more than 6 months, and resection was performed if the tumors became resectable during the treatment course.
The study's primary endpoint was the 1-year survival rate. Among the 39 patients who received the GSRT regimen, the 1-year survival rate was 64.1 percent. The median overall survival time was 16.6 months, and the median progression-free survival time was 8.7 months. The overall response rate was 25.6 percent, and the disease control rate was 79.5 percent.
Twelve patients successfully underwent radical resection. Within this surgically resected subgroup, the 1-year survival rate was 91.7 percent, the median overall survival time was 44.3 months, and the median survival time was 11.6 months. The treatment protocol demonstrated high tolerability, achieving a GSRT completion rate of 95 percent, with adverse events reported as well tolerated.
What The Evidence Shows
This clinical evidence comes from a prospective, open-label, single-arm, multicenter Phase 2 trial published in the journal Surgery today in September 2026. The trial is registered in the University Hospital Medical Information Network Clinical Trials Registry under the registration number UMIN 000011453. Because this is a single-arm study without a randomized control group, it cannot directly compare the outcomes of GSRT to other standard regimens.
What We Don't Know Yet
The published source text does not report specific details regarding the exact types, grades, or frequencies of the observed adverse events, nor does it detail why one of the 40 enrolled patients did not receive the treatment. Additionally, the source does not discuss limitations related to the lack of a randomized control arm or the sample size of 40 patients.
What Comes Next
The published source does not report any planned next steps, future trials, or subsequent analyses for this treatment regimen. Unanswered questions remain regarding how the GSRT protocol compares directly to other chemoradiotherapy standards in a randomized Phase 3 trial setting.
What This Means
The trial results suggest that concurrent full-dose gemcitabine, S-1, and radiation (GSRT) is a safe and effective treatment option for patients with locally advanced pancreatic ductal adenocarcinoma. The 95 percent completion rate indicates the regimen is highly tolerable, and the clinical outcomes show that a subset of patients can successfully transition to radical surgical resection.
Original Source
PubMed (NCBI E-utilities): https://pubmed.ncbi.nlm.nih.gov/42696140/
Questions readers ask
- What is the GSRT protocol for pancreatic cancer?
- The GSRT protocol is a chemoradiotherapy regimen that combines full-dose gemcitabine and S-1 chemotherapy administered concurrently with 50.4 Gy of radiation therapy.
- How did patients who underwent surgery after GSRT perform?
- Among the 12 patients who underwent radical resection, the 1-year survival rate was 91.7 percent, the median overall survival time was 44.3 months, and the median survival time was 11.6 months.
- Was the GSRT regimen well tolerated by patients?
- Yes, the GSRT regimen was well tolerated, achieving a completion rate of 95 percent among the 39 patients who received the treatment.
What this means
The trial results suggest that concurrent full-dose gemcitabine, S-1, and radiation (GSRT) is a safe and effective treatment option for patients with locally advanced pancreatic ductal adenocarcinoma. The 95 percent completion rate indicates the regimen is highly tolerable, and the clinical outcomes show that a subset of patients can successfully transition to radical surgical resection.
Limitations and uncertainties
- The published source text does not report specific details regarding the exact types, grades, or frequencies of the observed adverse events, nor does it detail why one of the 40 enrolled patients did not receive the treatment. Additionally, the source does not discuss limitations related to the lack of a randomized control arm or the sample size of 40 patients.
