Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer

NCT ID: NCT04258657

Last Updated: 2020-02-06

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

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-12-31

Brief Summary

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This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.

Detailed Description

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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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Paclitaxel-albumin and S-1

Group Type EXPERIMENTAL

paclitaxel-albumin and S-1

Intervention Type DRUG

neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer

Interventions

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paclitaxel-albumin and S-1

neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. pathologically diagnosed gastric adenocarcinoma
2. Type II and III esophageal-gastric-junction malignancy
3. AJCC stage II-III
4. No contraindications for surgery, radical resection can be expected
5. KPS\>60; ECOG score:0-2
6. Expactant survival period\>6 months
7. Age 20\~75
8. No other major health issues
9. Lab results within 7 days before inclusion must satisfy:

1. neutrophil≥1.5×109/L
2. PLT≥100×109/L
3. hemogloblin≥90g/L
4. ALT,AST\<1.5 upper limit
5. Tbil≤1.0×UNL
6. serum creatinine\<1.5×UNL
7. PT-INR/PTT\<1.7 upper limit
10. with measurable lesion according to RECIST1.1 criteria
11. with consent
12. co-operative

Exclusion Criteria

1. with other major health issue
2. allergic to relevant drugs
3. experienced any other drug therapy with 4 weeks before inclusion
4. experienced any drug therapy for gastric cancer at anytime
5. diagnosed with any other malignancy within the past 5 years
6. women at child-bearing age; pregnant or breast-feeding women
7. with severe heart disease
8. with upper GI digestion or disrupted absorption
9. with peripheral neural disease
10. with transplated organs or organs having been resected for transplantation
11. known DPD deficiency
12. with uncontrolled infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Deng

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Locations

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Zhongtao Zhang

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Zhongtao Zhang

Role: CONTACT

8618811792819 ext. 8618811792819

Facility Contacts

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Zhongtao Zhang

Role: primary

8618811792819 ext. 8618811792819

Other Identifiers

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BFH-GCCT

Identifier Type: -

Identifier Source: org_study_id

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