NCT05138159

A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen

A Prospective, Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of donafenib combined with S-1 in treating Patients with metastatic pancreatic cancer after chemotherapy with Nab-paclitaxel plus gemcitabine regimen.

Detailed description

While NG ( Nab-paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after NG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received donafenib and S-1. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. The efficacy and safety data will be assessed through OS, ORR, DCR, PFS,TTP and adverse effects as graded by NCI CTC-AE 5.0.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Donafenib	Donafenib: 200mg po bid.
DRUG	S1	S-1 capsule: According to the body surface area \<1.25m2 40mg/d, 1.25 \~ 1.5 m2 50 mg/d, \> 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-05-30
• Completion: 2023-07-30
• First posted: 2021-11-30
• Last updated: 2021-11-30

Locations

1 site across 1 country: China