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Status unknownNCT04135781Updated Mar 23, 2020

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

A Phase 3 interventional study of nab paclitaxel and Tegafur in Stomach Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-23.

Sponsored by Zhejiang Cancer Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
616
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 Ⅲ gastric cancer as adjuvant setting

Read the detailed 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 Ⅲ 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.

02

Conditions studied

  • Stomach Cancer

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Keywords

  • nab-paclitaxel
  • gastric cancer
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 616 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age of 18-75 years;
  2. Histological diagnosis of stage III gastric adenocarcinoma and Gastroesophageal junction of the stomach;
  3. Patients are required to provide a pathologically confirmed diagnosis report and provide 4-5 histological white films obtained at baseline;;
  4. Patients underwent D2 radical resection within 6 weeks prior to random enrollment; and R0 resection criteria were achieved;
  5. Ability to perform chemotherapy within 7 days of enrollment in the randomized group;
  6. No prior anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy for primary lesions;
  7. ECOG performance status of 0-1;
  8. Haematological status: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥100×109 /L, hemoglobin(HB) ≥90 g/L;WBC ≥3.0×109 /L;And no bleeding tendency;
  9. 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), or≤3 x upper limit of normal range (ULN) when with Gilbert's syndrome;
  10. kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN) or Creatinine clearance >60 ml/min (calculated according to Cockroft-Gault)
  11. Able and willing to comply with the study plans in this protocol and sign the informed consent;

Exclusion criteria

Exclusion Criteria:

  1. Treat with any other study drug or participate in another clinical trial with therapeutic intent within 28 days prior to enrollment;
  2. postoperative complications requiring clinical intervention and affecting treatment, such as stomach cramps, dumping syndrome;
  3. Patients known to be allergic or intolerant to clinical trial drugs;
  4. 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;
  5. Known active infection with HIV, hepatitis B or hepatitis C;
  6. 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;
  7. accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation;
  8. Female patients during pregnancy or lactation, who are refused to receive contraception during the childbearing age;
  9. The investigator judges patients who are not suitable for the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
616 participants (estimated)

Study arms

  • Experimental
    AS

    Arm A:nab paclitaxel (120mg/m2;iv;d1,8)+S-1 (\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid)Q3W;up to eight cycles

    Drug: nab paclitaxel · Drug: Tegafur

  • Active comparator
    XELOX

    Arm B:Capetabine(1000 mg/m2 po, d1-14 bid )+ Oxaliplatin(130mg/m2 , iv, d1)Q3W;up to eight cycles

    Drug: Oxaliplatin · Drug: Capecitabine

Interventions

  • Drugnab paclitaxel

    nab paclitaxel (120mg/m2;iv;d1,8)

    Also known as: albumin bound paclitaxel

  • DrugTegafur

    S-1 (\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid)

    Also known as: S-1

  • DrugOxaliplatin

    Oxaliplatin(130mg/m2 , iv, d1)

  • DrugCapecitabine

    Capetabine(1000 mg/m2 po, d1-14 bid )

06

What researchers measure

Primary outcomes

  1. 3 years Diseases-free Survival rate(3 years-DFS)

    DFS is defined as time from the date of inclusion up to the date of disease progression or death

    Time frame: up to 3 years

Secondary outcomes

  1. Overall survival (OS)

    Overall survival is defined as time from the start of treatment until death due to any reason.

    Time frame: up to 3 years

  2. Safety as measured by number and grade of adverse events

    Summary adverse events according to NCI-CTCAE 5.0

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences
    Hangzhou, Zhejiang 310022, China
    • Xiangdong Cheng, MD,PhD · Contact · Chengxd516@126.com · +86-571-88128202
    • Xiangdong Cheng, MD,PhD · Principal investigator
    • Yu Pengfei, MD,PhD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Cheng X, Wu D, Xu N, Chen L, Yan Z, Chen P, Zhou L, Yu J, Cui J, Li W, Wang C, Feng W, Wei Y, Yu P, Du Y, Ying J, Xu Z, Yang L, Zhang Y. Adjuvant albumin-bound paclitaxel combined with S-1 vs. oxaliplatin combined with capecitabine after D2 gastrectomy in patients with stage III gastric adenocarcinoma: a phase III multicenter, open-label, randomized controlled clinical trial protocol. BMC Cancer. 2021 Jan 12;21(1):56. doi: 10.1186/s12885-020-07772-7. PubMed 33435909 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04135781
Lead sponsor
Zhejiang Cancer Hospital
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
Responsible party
Xiangdong Cheng (Director, Zhejiang Cancer Hospital) — Principal investigator
First posted
Oct 23, 2019
Start date
Mar 1, 2020
Primary completion
Oct 31, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Mar 23, 2020

Study contacts

Cheng xiangdong, PhD
Contact
Chengxd516@126.com
0571-88128041
Yu pengfei, PhD
Contact
ypfzmu@163.com
0571-88128041
Cheng xiangdong, PhD
study chair · Zhejiang Cancer Hospital;Cancer hospital of the university of chinese academy of sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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