Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer

NCT04808687 | Unknown Phase 2

• 1 other identifier: TZ-PC02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Percentage of patients who achieve partial response (PR) or complete response(CR) based on Response Evaluation Criteria In Solid Tumors (RECIST1.1)

  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 Outcomes (3)

• R0/R1 resection rate

  2 years

• Disease free survival

  From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months

• Overall survival

  From date of randomization until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months

Study Arms (1)

nab-paclitaxel and S-1

EXPERIMENTAL

neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 2-4 cycles

Drug: Nab paclitaxel and S-1

Interventions

Nab paclitaxel and S-1 DRUG

Nab-Paclitaxel: 125 mg/m2 d1, 8, during each 3-week cycle. S-1: Body surface area \< 1.25 m2, 40 mg bid; Body surface area ≥ 1.25 m2 \< 1.50 m2, 50 mg bid; Body surface area ≥1.5 m2, 60 mg bid, d1-14;during each 3-week cycle.

nab-paclitaxel and S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed-consent form;
• Treatment-naive PDAC with histological or cytological diagnosis;
• Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;
• Age≥18 years old and ≤70 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• BMI≥18.5 and NRS2002score\<3;
• Expected survival over 3 months;
• Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;

You may not qualify if:

• Severe Impaired organ functions;
• Pregnant women or lactating women;
• Ineligible by the discretion of the investigator.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 30000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Taxes; S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Central Study Contacts

Jihui Hao

CONTACT

022-23340123-3077; tjzlyypc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)