Frontiers in medicine · 2026
Nimotuzumab combined with gemcitabine and nab-paclitaxel as first-line therapy for advanced pancreatic cancer: a single-arm, single-center Phase II prospective study.
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Lin Lin, Zhao Xinyi, Luo Yawen, Cai Jia-Hua, Lin Zhihuan, Xiao Liang, Tian Geng, He Shaozhong
Аннотация
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/m2 (days 1 and 8), and nab-paclitaxel 125 mg/m2 (days 1 and 8) every 21 days for up to 6 cycles. The primary endpoint was objective response rate (ORR), assessed per RECIST v1.1; secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR), duration of response (DOR), and safety, graded per NCI-CTCAE v5.0.
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.
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/m2 (days 1 and 8), and nab-paclitaxel 125 mg/m2 (days 1 and 8) every 21 days for up to 6 cycles. The primary endpoint was objective response rate (ORR), assessed per RECIST v1.1; secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR), duration of response (DOR), and safety, graded per NCI-CTCAE v5.0.
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.