Nab-paclitaxel Combined With S-1 as Adjuvant Chemotherapy for Stage Ⅲ Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    616
  • sponsor
    Zhejiang Cancer Hospital
Updated on 1 March 2022
platelet count
gastrectomy
paclitaxel
oxaliplatin
gastric adenocarcinoma
neutrophil count
capecitabine
cancer chemotherapy
adenocarcinoma
adjuvant chemotherapy
tegafur
immunostimulants
xelox regimen

Summary

This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage gastric cancer as adjuvant setting

Description

This is a randomized, open-label phase III study. The treatment was compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus capecitabine (XELOX) treating stage gastric cancer as adjuvant setting. The primary endpoint is the 3-year diseases-free survival (DFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Details
Condition Stomach Cancer
Treatment Capecitabine, Oxaliplatin, nab paclitaxel, Tegafur
Clinical Study IdentifierNCT04135781
SponsorZhejiang Cancer Hospital
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age of 18-75 years
Histological diagnosis of stage III gastric adenocarcinoma and Gastroesophageal junction of the stomach
Patients are required to provide a pathologically confirmed diagnosis report and provide 4-5 histological white films obtained at baseline
Patients underwent D2 radical resection within 6 weeks prior to random enrollment; and R0 resection criteria were achieved
Ability to perform chemotherapy within 7 days of enrollment in the randomized group
No prior anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy for primary lesions
ECOG performance status of 0-1
Haematological status: absolute neutrophil count(ANC) 1.5109 /L, platelet count(PLT) 100109 /L, hemoglobin(HB) 90 g/L;WBC 3.0109 /L;And no bleeding tendency
Liver function: alanine glutamate transaminase (ALT) and glutamate transaminase (AST) 2.5 x upper limit of normal range (ULN), alkaline phosphatase 2.5 x upper limit of normal range (ULN)total bilirubin (TBIL)1.5 x upper limit of normal range (ULN), or3 x upper limit of normal range (ULN) when with Gilbert's syndrome
kidney function: Creatinine(Cr)1.5 x upper limit of normal range(ULN) or Creatinine clearance >60 ml/min (calculated according to Cockroft-Gault)
Able and willing to comply with the study plans in this protocol and sign the informed consent

Exclusion Criteria

Treat with any other study drug or participate in another clinical trial with therapeutic intent within 28 days prior to enrollment
postoperative complications requiring clinical intervention and affecting treatment, such as stomach cramps, dumping syndrome
Patients known to be allergic or intolerant to clinical trial drugs
investigator believes will affect the subject's treatment regimen, uncontrolled serious medical diseases, including severe heart disease (such as the New York Heart Association (NYHA) Level II or more Congestive heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection
Known active infection with HIV, hepatitis B or hepatitis C
Other serious and uncontrolled non-malignant disease; except adequately treated cervical carcinoma in situ, non-melanoma skin Localized prostate cancer after cancer and radical surgery (PSA 10 ng/ml); no recurrence or metastasis was found based on imaging follow-up results and any disease-specific tumor markers
accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation
Female patients during pregnancy or lactation, who are refused to receive contraception during the childbearing age
The investigator judges patients who are not suitable for the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note