Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

• Status: Unknown status
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Pancrelipase

Criteria

Inclusion Criteria:

• Histological or cytological confirmation of pancreatic adenocarcinoma

• Distant metastatic or unresctable locally advanced diseases

• CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment

• At least one lesion measurable by RECIST v1.1 criteria

• Life expectancy> 3 months

• No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)

• No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)

• Pain must be monitored before inclusion

• 18 years < age < 70

• Performance status: 0-1

• ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL

• ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found

• Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),

• creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min

• Patient information and signature of informed consent

Exclusion Criteria:

• Concurrent other effective treatment (including radiotherapy)

• Resectable patients

• Allergy history to other drugs in the same class patients with pregnancy or lactation

• Known severe internal medical diseases

• Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia

• Immunocompromised patients, such as HIV positive

• Uncontrollable mental illness

• Other conditions the researchers considered ineligible for the study