Trial reportFrontiers in medicine2026
Nimotuzumab combined with gemcitabine and nab-paclitaxel as first-line therapy for advanced pancreatic cancer: a single-arm, single-center Phase II prospective study.
Trial report in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
Background: Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate of merely 8% for exocrine tumors, and conventional chemotherapy offering limited clinical benefit. Nab-paclitaxel plus gemcitabine (AG) is a standard first-line regimen, yet outcomes remain suboptimal. Nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody with a favorable tolerability profile, has demonstrated promising activity in combination with gemcitabine in KRAS wild-type pancreatic cancer. Objective: This study aimed to preliminarily evaluate the efficacy and safety of nimotuzumab combined with gemcitabine and nab-paclitaxel (NTZ-AG) as first-line therapy in patients with locally advanced or metastatic pancreatic cancer. Methods: This single-arm, single-center Phase II prospective study enrolled 16 patients (aged 18-75 years, ECOG PS 0-1) with pathologically confirmed Stage III-IV pancreatic cancer without prior systemic chemotherapy. Patients received nimotuzumab 400 mg (day 1, 3-h infusion), gemcitabine 1,000 mg/m Results: Among 16 evaluable patients, the ORR was 68.75% (11/16; 95% CI: 42.81-87.34%), with no complete responses and 11 partial responses. The disease control rate (DCR) was 100%. Median PFS was 6.0 months (95% CI: 4.06-7.95) and median OS was 12.0 months (95% CI: 8.35-15.66), with one patient achieving an OS of 49 months. Adverse events were predominantly Grade 1-2; no Grade 4 or higher toxicities were observed. Grade 3 events included alopecia (81.2%), nausea (12.5%), and myelosuppression. Conclusion: The NTZ-AG regimen demonstrated meaningful anti-tumor activity and an acceptable safety profile as first-line therapy for unselected advanced pancreatic cancer patients, providing a rational basis for larger randomized controlled trials. Clinical trial registration: This trial was registered at the Chinese Clinical Trial Register (ChiCTR) under the registration number ChiCTR2300072843 having URL https://www.chictr.org.cn/showprojEN.html?proj=198791.
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