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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 2

Conditions: Nab-paclitaxel; Gemcitabine; S1; Pancreatic Cancer

Treatments: Drug: S1 or Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03779464

XHZL-001

Details and patient eligibility

About

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

Full description

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

S/nab

Experimental group

Description:

Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)

Treatment:

Drug: S1 or Gemcitabine

Gem/nab

Active Comparator group

Description:

Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)

Treatment:

Drug: S1 or Gemcitabine