Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— ASAGPAC  

Official title:

Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03636308
• Other study ID #: ASAG01
• Status: Recruiting
• Phase: Phase 2
• Start date: July 17, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2018
• Source: Peking University
• Contact: Jun Zhou
• Phone: 861088196561
• Email: 13366152815[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Description:

Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed-consent form.

2. Age no less than 18 years.

3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.

4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.

5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.

6. At least 4 weeks since completion of the last operation except for diagnostic biopsy.

7. At least 4 weeks since completion of radiotherapy to lesions.

8. Not suitable for local treatment.

9. Adequate liver/bone marrow function.

10. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.

11. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.

2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.

3. Serious infection requiring antibiotics intervention during recruitment.

4. Allergic to study drug.

5. More than grade 1 neuropathy.

6. Uncontrolled brain metastasis or mental illness.

7. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.

8. Other malignancy within 5 years.

9. Can't be followed up or obey protocol.

10. Ineligible by the discretion of the investigator.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.
• S1
S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2=BSA=1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
• Gemcitabine
Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital and Institute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Objective response rate of primary tumor	Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)(every 3 cycles in AS or every 2 cycles in AG).	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Progression-free survival	Measure of time from study treatment to disease progression or death.	up to 15 months
Secondary	Overall survival	Measure of time from study treatment to patient's death or lost to follow-up.	up to 2 years
Secondary	Disease control rate	The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	The incidence of treatment related emergent adverse events(Safety and Tolerance)	Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version	Until 28 days after the deadline of enrollment