Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka - LARVOL DELTA

Cadonilimab combined with trastuzumab and chemotherapy for HER2-positive gastric cancer with bone marrow metastasis and DIC: a case report and literature review. (PubMed, Front Immunol) - "Given her ECOG performance status of 2, initial therapy consisted of trastuzumab combined with docetaxel and fluorouracil, alongside supportive care...Treatment was then escalated to a combination of cadonilimab, trastuzumab, and FLOT (5-FU, leucovorin, oxaliplatin, docetaxel)...This case demonstrates that intensive anti-tumor therapy combining HER-2-targeted agents, ICIs, and chemotherapy, alongside supportive care, can prolong survival and improve life quality in GC patients with BMM and DIC. Hematologic toxicities were the main adverse events but were tolerable, supporting the regimen's feasibility and safety."

IO biomarker • Journal • Review • Allergy • Gastric Adenocarcinoma • Gastric Cancer • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Pain • Solid Tumor • HER-2 • PD-L1

A phase I study of S-1 and cisplatin with concurrent hypofractionated carbon-ion radiotherapy for patients with stage III non-small cell lung cancer (Front Oncol) - "Six patients were enrolled in this study. At level 1, one patient experienced grade 3 elevated alanine aminotransferase and aspartate aminotransferase levels, which is regarded as a dose-limiting toxicity. This event improved immediately. Five patients developed grade 2 esophagitis. In three of the five patients, symptoms such as pain and dysphagia due to esophagitis recurred several months after resolution of the acute esophagitis that occurred during irradiation. None of the patients experienced adverse events of ≥grade 3."

P1 data • Non Small Cell Lung Cancer

Camrelizumab plus SOX chemotherapy as adjuvant therapy for pathological stage III gastric or gastroesophageal junction adenocarcinoma: a prospective, multicenter, single-arm, phase II trial. (PubMed, Ther Adv Med Oncol) - P2 | "Patients with pStage III G/GEJ adenocarcinoma were enrolled, receiving camrelizumab (200 mg), followed by oxaliplatin (130 mg/m2), both administered on day 1 of each 21-day cycle, and tegafur-gimeracil-oteracil potassium capsules (40-60 mg, twice daily) for 2 weeks, followed by a 7-day rest period. However, careful patient selection is necessary to identify patients most likely to benefit from combination therapy. ClinicalTrials.gov registry: NCT04515615; Date of registration: August 14, 2020; Weblink: https://clinicaltrials.gov/study/NCT04515615."

Journal • P2 data • Endocrine Disorders • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Infectious Disease • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombocytopenia

Long-term outcomes of S-1 monotherapy in stage IIIA gastric cancer with small tumors and low nodal involvement. (PubMed, Langenbecks Arch Surg) - "S-1 monotherapy may be associated with favorable long-term outcomes in selected patients with stage IIIA gastric cancer who have small tumors and low lymph node positivity rates. While these results are encouraging, they should not be interpreted as a rationale for broadly recommending S-1 monotherapy. Further studies are needed to define its role in individualized treatment strategies."

Journal • Monotherapy • Retrospective data • Gastric Cancer • Oncology • Solid Tumor

A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010 (clinicaltrials.gov) - P1 | N=102 | Active, not recruiting | Sponsor: Genentech, Inc. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Checkpoint inhibition • Trial completion date • Trial primary completion date • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

Real-world treatment patterns and outcomes in patients with advanced gastric cancer in Japan (ESMO-GI 2025) - "Nivo+S-1+oxaliplatin (2705/7839; 34.5%) was the most common 1L regimen in overall cohort. Most common 2L and 3L regimens were ramucirumab (Ram) combination (1910/2641; 72.3%) and Nivo (312/931; 33.5%), respectively...Factors positively associated with transition to 2L were duration of 1L Tx ≥150 days (OR [95% CI]: 2.5, [2.2–2.8]), 1L Trastuzumab (1.8, [1.5–2.2]), and 1L Nivo (1.5, [1.3–1.7])... After 1L Nivo was introduced for AGC in Japan, treatment patterns remained consistent with JGCA guidelines. Optimizing sequential therapy in Japan will contribute to better outcomes."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Gastric Cancer • Oncology • Solid Tumor

Outcomes of a rectal cancer population treated with capecitabine-based chemoradiation compared with a cohort switched to S-1 for cardiotoxicity (ESMO-GI 2025) - P | "S-1 is a safe and effective alternative for patients who develop cardiotoxicity on capecitabine-based CRT for rectal cancer that allows patients to complete their curative-intent therapy."

Clinical • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Prolonged Progression-Free Survival in a Patient with Highly Pretreated Recurrent Ovarian Cancer after Developing Multisystem Immune-Related Adverse Events: A Case Report and Literature Review. (PubMed, Case Rep Oncol) - "Between 2013 and 2021, she underwent palliative chemotherapy comprising paclitaxel liposomes, cisplatin/nedaplatin, S-1/raltitrexed, irinotecan, doxorubicin, vinorebine, toripalimab, apatinib, gemcitabine, oxaliplatin, and capecitabine, as well as two debulking surgeries. From November 2021, she received six cycles of tislelizumab (a PD-1 inhibitor), paclitaxel (albumin-bound), and carboplatin, to which a partial response was observed according to the Response Evaluation Criteria in Solid Tumors. From May 2022, the patient was switched to maintenance therapy with tislelizumab plus olaparib...We report a case involving a patient with highly pretreated recurrent ovarian cancer who exhibited prolonged PFS after developing three irAEs. The distinctly prolonged PFS observed, along with the reviewed literature, suggests that irAEs may be correlated with improved survival in ovarian cancer."

Adverse events • IO biomarker • Journal • Tumor mutational burden • Endocrine Disorders • Gynecology • Microsatellite Instability • Nephrology • Obstetrics • Oncology • Ovarian Cancer • Pneumonia • Renal Disease • Solid Tumor • MSI • TMB

Early safety and efficacy from the phase IIIb TOURMALINE study of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in advanced biliary tract cancer (aBTC) (ESMO-GI 2025) - P3 | "Early safety and efficacy data are reported. Participants (pts) received D 1500 mg with an investigator-selected G-based chemotherapy (D + G alone or in combination with oxaliplatin, carboplatin, cisplatin [cis], tegafur-gimeracil-oteracil [S-1], cis + S-1, or cis + nab-paclitaxel). The safety profiles of all study tx were manageable. ORR data are immature but overall ORR is comparable to the TOPAZ-1 study."

Clinical • Combination therapy • Metastases • P3 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Conversion surgery of stage 4 gastric cancer with peritoneal dissemination after overcoming immune-related liver injury: a case report and literature review. (PubMed, Int Cancer Conf J) - "Postoperative chemotherapy with S-1, oxaliplatin, and nivolumab was initiated...This case demonstrated successful downstaging using chemotherapy with ICIs and subsequent radical resection via conversion surgery. Thus, conversion surgery is a viable option for multidisciplinary gastric cancer treatment and may see increased application with aggressive chemotherapy plus ICI regimens for managing metastatic or unresectable gastric cancer."

Journal • Gastric Cancer • Hepatology • Liver Failure • Oncology • Solid Tumor

Adjuvant chemotherapy of S-1 plus metformin versus S-1 for radical resection of pancreatic cancer: Multicenter randomized phase II trial (ESMO-GI 2025) - "The addition of metformin at routine doses to resected pancreatic cancer patients receiving standard adjuvant chemotherapy did not signifficantly improve outcomes. This study used a new regimen of S-1, with 2 weeks on and 1 week off per cycle, which was found to have similar efficacy and superior safety to conventional regimens in both treatment arms."

Clinical • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age (clinicaltrials.gov) - P2 | N=56 | Completed | Sponsor: The First Affiliated Hospital with Nanjing Medical University | Enrolling by invitation ➔ Completed | Phase classification: P1 ➔ P2 | Trial completion date: Jul 2028 ➔ Jan 2025 | Trial primary completion date: Jul 2025 ➔ Jan 2025

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • EGFR

Chemotherapy (SOX) plus tisleizumab in gastric cancer patients with liver metastasis: The first report from a multi-center phase II study (ESMO-GI 2025) - P2/3 | "Enrolled patients receive chemotherapy (SOX, S-1 and oxaliplatin, Q3W) plus Tisleizumab (200mg, Q3W) for 6-8 cycles, and maintenance therapy is oral S-1 within 1 year plus Tisleizumab (200mg, Q3W) within 2 years, or until disease progression. 18 patients were enrolled from March 2022 to January 2025, median follow-up at March 2025 was 13.17 months (8.59-17.74)... Chemotherapy (SOX) plus Tisleizumab has been shown to improve treatment efficiency and prognosis for GC patients with LM."

Clinical • P2 data • Gastric Cancer • Oncology • Solid Tumor • MSI

Conversion therapy with sintilimab combined with chemotherapy and apatinib in stage IV gastric cancer. (PubMed, Int J Cancer) - "We explored the feasibility and efficacy of sintilimab plus two-drug chemotherapy (S-1 plus nab-paclitaxel) and apatinib as conversion therapy in patients with stage IV gastric cancer in China...The safety profile was manageable. Sintilimab plus chemotherapy and apatinib followed by conversional resection may be a new feasible and safe option for initially unresectable gastric cancer, potentially leading to long-term survival or even cure."

Journal • Gastric Cancer • Oncology • Solid Tumor

Efficacy and safety of sintilimab combined with nab-paclitaxel plus S-1 for neoadjuvant treatment of locally advanced gastric cancer. (PubMed, World J Gastrointest Surg) - "The combination of sintilimab with nab-paclitaxel + S-1 for neoadjuvant treatment of LAGC improved efficacy in patients without increasing adverse drug reactions and perioperative adverse events, suggesting that this treatment regimen is safe and feasible."

Journal • Gastric Cancer • Oncology • Solid Tumor

Nivolumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Korean Patients with HER2-Negative, Untreated, Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer: Subgroup Analysis of a Randomized, Multicenter, Double-Blind Phase 3 Trial (ATTRACTION-4). (PubMed, Cancer Res Treat) - P2/3 | "Patients received nivolumab or placebo, both combined with physician-choice chemotherapy (oxaliplatin plus oral S-1 [tegafur‒gimeracil‒oteracil] [SOX] or oral capecitabine [CAPOX]). Grade ≥3 treatment-related adverse events (TRAEs) (56.1% vs. 44.1%), and any-grade endocrine (9.5% vs. 4.2%), hepatic (23.0% vs. 14.7%), hypersensitivity and infusion reactions (15.5% vs. 7.0%), renal (4.1% vs. 0.7%), and skin (44.6% vs. 23.1%) TRAEs tended to be more frequent in the nivolumab + chemotherapy group. These findings demonstrate the clinical benefit of nivolumab combined with chemotherapy (either SOX or CAPOX) for first-line treatment of gastric cancer/gastroesophageal junction cancer in Korean patients."

Clinical • Journal • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Immunology • Oncology • Oral Cancer • Solid Tumor • HER-2

Computed tomography 3D reconstruction and texture analysis for evaluating the efficacy of neoadjuvant chemotherapy in advanced gastric cancer. (PubMed, World J Gastrointest Surg) - "The CT 3D reconstruction volume change rate can serve as a preferred quantitative indicator for evaluating the efficacy of neoadjuvant chemotherapy in GC. Combining it with a CT visual feature predictive model can further improve the accuracy of efficacy evaluation."

Journal • Gastric Cancer • Oncology • Solid Tumor

Hyperprogression disease induced by Sintilimab combined with Oxaliplatin and S-1 after surgery: a case report and literature review. (PubMed, Front Oncol) - "Although immune checkpoint inhibitors (ICIs) have demonstrated significant efficacy in cancer treatment, HPD induced by ICIs can drastically shorten patients' OS, warranting cautious use in populations with high-risk factors. Effective prevention of HPD involves screening for risk factors, monitoring predictive biomarkers such as circulating-free DNA (cfDNA) via liquid biopsy, and identifying high-risk populations through gene mutation analysis."

IO biomarker • Journal • Gastric Cancer • Oncology • Solid Tumor • EGFR • FGFR1 • MET • PD-1 • TP53

Perioperative 5-Fluorouracil and Portal Vein Infusion Chemotherapy Followed by Adjuvant S-1 for Resected Pancreatic Cancer (TOSPAC-02): A Phase 2 Clinical Trial. (PubMed, Ann Surg Oncol) - "PI4W followed by S-1 therapy may benefit patients after curative resection of PDAC. Clinical trial register: The study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000013430)."

Journal • P2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Prognostic Significance of Post-Neoadjuvant Chemotherapy Carbohydrate Antigen 19-9 Levels in Patients With Resectable Pancreatic Cancer Treated With S-1 and Gemcitabine: A Retrospective Cohort Study. (PubMed, World J Oncol) - "The CA19-9 cut-off value is clinically significant for patients undergoing NATGS regimens. Patients with pre-operative CA19-9 levels ≥ 100 U/mL may benefit from extended GS treatment or a switch to a more potent regimen rather than proceeding directly to surgical resection."

Journal • Retrospective data • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9

A Case of Unresectable Gastric Cancer Successfully Treated with Conversion Surgery After Immunotherapy Including Treatment. (PubMed, Tokai J Exp Clin Med) - "A 72-year-old woman diagnosed as unresectable advanced gastric cancer with both of direct invasion to liver and pancreas and peritoneal dissemination, received 11 courses of S-1 and oxaliplatin (SOX) + nivolumab combination therapy according to the Japanese Gastric Cancer Treatment Guideline because the tumor showed HER2-negative, microsatellite instability (MSI)-high, and PD-L1-positive...Postoperative histopathological examination showed no residual tumor cells both in the primary tumor and dissected lymph nodes. Postoperatively, the patient was treated with SOX therapy for 1 year and remains alive at 16 months postoperatively without recurrence."

Journal • Gastric Cancer • Microsatellite Instability • Oncology • Solid Tumor • HER-2 • MSI

Descending duodenal adenocarcinoma treated with pembrolizumab resulting in complete clinical response: A case report and literature review. (PubMed, World J Gastrointest Oncol) - "Patients with MSI-H DDA exhibiting high PD-L1 expression who are treated with pembrolizumab can achieve sustained CCR."

IO biomarker • Journal • Gastroenterology • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Small Intestinal Carcinoma • Solid Tumor • MSI

Extended progression-free survival after combination treatment with anlotinib and S-1 in refractory advanced esophageal cancer: A case report. (PubMed, Mol Clin Oncol) - "Tumor progression continued after multiline chemotherapy with paclitaxel, platinum and irinotecan; immunotherapy with camrelizumab; and radiotherapy...As fourth-line therapy, anlotinib was administered in combination with S-1. Thereafter, the patient's progression-free survival was 16.7 months, indicating that anlotinib combined with S-1 may be effective in refractory advanced esophageal cancer."

Journal • Cardiovascular • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Disorder • Hematological Disorders • Oncology • Squamous Cell Carcinoma

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer (clinicaltrials.gov) - P1/2 | N=55 | Recruiting | Sponsor: Ruijin Hospital

New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

NeoRacing: Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer (clinicaltrials.gov) - P2 | N=6 | Terminated | Sponsor: Fudan University | N=152 ➔ 6 | Recruiting ➔ Terminated; Difficult in recruiting participants

Enrollment change • IO biomarker • Trial termination • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor