NCT04581876

The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic Cancer

A Single-arm, Prospective Study to Evaluate the Safety and Efficacy and of the Combination of Raltitrexed for Injection and Nab-Paclitaxel as Second-line Therapy in Treating Patients With Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The present study is intended to investigate the safety and efficacy of the patients with confirmed advanced pancreatic cancer after treating with the combination of raltitrexed for injection and nab-paclitaxel.

Detailed description

Conditions: Advanced pancreatic cancer subjects which were prospectively to receive first-line chemotherapy. Keywords: Advanced pancreatic cancer; paclitaxel liposome; S-1 Interventions: Drug: paclitaxel liposome; Drug:S-1 Phase: Phase IV Study Type: Interventional Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Primary Purpose: Treatment MedlinePlus related topics: Cancer, Pancreatic Cancer Drug Information available for: paclitaxel liposome：paclitaxel liposome for injection S-1：Tegafur, Gimeracil and Oteracil Potassium Capsules Primary Outcome Measures: To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. Secondary Outcome Measures: To evaluate the Overall Response Rate、overall survival、disease control rate、Quality of Life、adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.

Conditions

• Pancreatic Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	raltitrexed for injection	Patients receive raltitrexed 2mg/m2 (iv, 15min) on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.
DRUG	nab-paclitaxel	Patients receive nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-09-01
• Completion: 2023-03-01
• First posted: 2020-10-09
• Last updated: 2020-10-09

Locations

1 site across 1 country: China