OncoMatch/Clinical Trials/NCT06199895
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer
Is NCT06199895 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Paclitaxel Polymeric Micelles for for pancreatic adenocarcinoma.
Treatment: Paclitaxel Polymeric Micelles for — This study is a single-center, single-arm, open-label, phase II clinical trial designed to evaluate the efficacy and safety of Paclitaxel Polymeric Micelles for Injection for the treatment of patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer that are resistant to Taxanes. Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment. If subject does not develop disease progression , the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up. This is a single-arm, small-sample clinical study with the primary efficacy goal of objective remission rate (ORR). The parameters of the trial were set: assuming a class I error of 0.025 unilaterally, power=90%, and a 15% improvement in ORR for objective remission rate, a total of 20 subjects would be required, and a total of 25 would be required for enrolment, taking into account a 20% shedding.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Cholangiocarcinoma
Non-Small Cell Lung Carcinoma
Gastric Cancer
Esophageal Carcinoma
Breast Carcinoma
Disease stage
Metastatic disease required
advanced ... diagnosed by histological or cytological pathology; must have an evaluable lesion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: taxane
Previous treatment regimen includes Taxanes and is resistant to Taxanes (including patients with initial failure to remit or progression after remission) or previous use of Taxanes for at least 2 cycles without tumour shrinkage and the patient is not satisfied with current stable efficacy and is willing to be enrolled in this study
Lab requirements
Blood counts
WBC≥3.0×10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥80g/L
Kidney function
Creatinine clearance (Cockcroft-Gault) ≥50 ml/min
Liver function
Total bilirubin ≤1.5×ULN; AST, ALT, or ALP ≤2.5×ULN (≤5×ULN for liver metastases, ALP≤10×ULN for bone metastases)
Cardiac function
Functions of major organs such as heart, lung, liver and kidney are basically normal
Blood routine examination meets the following criteria: WBC≥3.0×10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥80g/L; Blood biochemical examination: Total bilirubin ≤1.5×ULN; AST, ALT, or ALP ≤2.5×ULN (≤5×ULN for liver metastases, ALP≤10×ULN for bone metastases); Creatinine clearance (Cockcroft-Gault) ≥50 ml/min; Functions of major organs such as heart, lung, liver and kidney are basically normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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