OncoMatch/Clinical Trials/NCT05841420
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
Is NCT05841420 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Nab paclitaxel for pancreas cancer.
Treatment: Gemcitabine · Nab paclitaxel — The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer, who are unfit for full-dose combination chemotherapy. The patients will be equally randomized to arm A or arm B: Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8,and 15 every 4 weeks. Arm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks) Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible
Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)
Lab requirements
Blood counts
anc ≥1.5 x 10^9/l and platelets count ≥100x10^9/l
Kidney function
egfr >50ml/min
Liver function
bilirubin ≤1.5 x unl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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