Efficacy And Safety Of Nab-Paclitaxel Plus S-1 In The First-line Treatment Of Advanced Pancreatic Cancer

Study Overview

Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.

Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer. Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan. We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen.

Advanced Pancreatic Cancer

DRUG: Nab-paclitaxel and S-1

CH-GI-062

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-01-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-01-29
First Submitted that Met QC Criteria 2018-01-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-01
First Posted (ACTUAL) 2018-01-30	Results First Posted N/A	Last Verified 2021-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nab-paclitaxel Plus S-1 Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)	DRUG: Nab-paclitaxel and S-1 Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nab-paclitaxel Plus S-1

Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)

DRUG: Nab-paclitaxel and S-1

Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate（ORR）	CR+PR was defined as objective response rate (ORR)	6 month

Secondary Outcome Measures	Measure Description	Time Frame
DCR	CR+PR+SD was defined as disease control rate (DCR)	6 month
PFS	From date of randomization until date of first documented PD, date of death	6 month
OS	From date of randomization until date of death	1 year
Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer	Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age, years: 18-75
Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
Both male and female subjects of potential fertility have to agree effective birth control during the entire study
Informed consent

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Aiping Zhou, Doctor, National Cancer Center/Cancer Hospital, China

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record