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

NCT ID: NCT04135781

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-10-31

Brief 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

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.

Conditions

Stomach Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

nab paclitaxel

Intervention Type: DRUG

nab paclitaxel （120mg/m2；iv；d1，8）

Tegafur

Intervention Type: DRUG

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）

XELOX

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

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin（130mg/m2 , iv, d1）

Capecitabine

Intervention Type: DRUG

Capetabine（1000 mg/m2 po, d1-14 bid ）

Interventions

nab paclitaxel

nab paclitaxel （120mg/m2；iv；d1，8）

Intervention Type: DRUG

Tegafur

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）

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin（130mg/m2 , iv, d1）

Intervention Type: DRUG

Capecitabine

Capetabine（1000 mg/m2 po, d1-14 bid ）

Intervention Type: DRUG

Other Intervention Names

albumin bound paclitaxel; S-1

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiangdong Cheng

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng xiangdong, PhD

Role: STUDY_CHAIR

Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences

Locations

Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cheng xiangdong, PhD

Role: CONTACT

Chengxd516@126.com

0571-88128041

Yu pengfei, PhD

Role: CONTACT

ypfzmu@163.com

0571-88128041

Facility Contacts

Xiangdong Cheng, MD，PhD

Role: primary

Chengxd516@126.com

+86-571-88128202

References

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.

Reference Type: DERIVED

PMID: 33435909 (View on PubMed)

Other Identifiers

CSPC-KAL-GC-04

Identifier Type: -

Identifier Source: org_study_id