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

Phase 2

• Conditions: Gemcitabine; Pancreatic Cancer; Nab-paclitaxel; S1
• Interventions: Drug: S1 or Gemcitabine

• Registration Number: NCT03779464
• Lead Sponsor: Wuhan Union Hospital, China

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Study Start: 2019-08-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S/nab	S1 or Gemcitabine	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)
Gem/nab	S1 or Gemcitabine	Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)

Primary Outcome Measures

Name	Time	Method
PFS	6 month	progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	1 year	overall survival
Safety profile :Adverse events of nab-Paclitaxel plus S-1	1 year	Adverse events of nab-Paclitaxel plus S-1
DCR	6 month	CR+PR+SD was defined as disease control rate (DCR)
ORR	6 month	objective response rate

Trial Locations

Locations (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China