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

NCT ID: NCT03977220

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nab-paclitaxel combined with S-1

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

Group Type EXPERIMENTAL

Nab-paclitaxel combined with S-1

Intervention Type DRUG

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

Interventions

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Nab-paclitaxel combined with S-1

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tianshu Liu

Chairman for the department of oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Cui Y, Yu Y, Yu S, Li W, Wang Y, Li Q, Liu T. Phase I study of adjuvant chemotherapy with nab-paclitaxel and S-1 for stage III Lauren's diffuse-type gastric cancer after D2 resection (NORDICA study). Cancer Med. 2023 Jan;12(2):1114-1121. doi: 10.1002/cam4.4966. Epub 2022 Jun 25.

Reference Type DERIVED
PMID: 35751496 (View on PubMed)

Other Identifiers

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NORDICA

Identifier Type: -

Identifier Source: org_study_id

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