Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase I Study: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer as Adjuvant Setting (NORDICA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03977220
• Other study ID #: NORDICA
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2019
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Description:

Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• gastric cancer patients after radical resection

• diffuse type gastric cancer stage III

Exclusion Criteria:

• Patients who have metastasis disease

• Patients who can not tolerate chemotherapy

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Nab-paclitaxel combined with S-1
Nab-paclitaxel combined with S-1 treating diffuse type of stage ? gastric cancer as adjuvant setting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended dose for Phase II study		through study completion, an average of 2 year