Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03801668
• Other study ID #: TJCC008
• Status: Recruiting
• Phase: Phase 3
• Start date: March 8, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2022
• Source: Huazhong University of Science and Technology
• Contact: Xianglin Yuan, MD,PhD
• Phone: 8627-83663406
• Email: xlyuan1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age of 18-75 years;

2. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;

3. At least one measurable lesion as defined by RECIST 1.1 criteria;

4. ECOG performance status of 0-1;

5. Estimated life expectancy of at least 3 months;

6. Left ventricular ejection fraction (LVEF) = 50%;

7. Bone marrow function: absolute neutrophil count(ANC) =1.5×109 /L, platelet count(PLT) =90×109 /L, hemoglobin(HB) =90 g/L;

8. Liver and kidney function: Creatinine(Cr)=1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) =2.5 x upper limit of normal range (ULN), or =5 x upper limit of normal range (ULN)when with hepatic metastases,total bilirubin (TBIL)=1.5 x upper limit of normal range (ULN), or=2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;

9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;

10. Able and willing to comply with the study plans in this protocol and sign the informed consent;

Exclusion Criteria:

1. Have received chemotherapy before;patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;

2. HER-2 positive;

3. Patients with symptomatic brain metastases;

4. II-IV peripheral neuropathy [NCI-CTCAE 4.03];

5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;

6. Patients with serious systemic infection or other diseases;

7. Allergic to the chemotherapy drugs or the materials in this study;

8. Patients with gastrointestinal bleeding that need clinical intervention;

9. Patients with digestive tract obstruction or oral nutrition difficulty;

10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;

11. Have participated in other clinical trials within 28 days prior to the first dose of this study;

12. Contraindications to chemotherapy;

13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Albumin-bound Paclitaxel plus S-1
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
• Oxaliplatin plus S-1
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.

Locations

Country	Name	City	State
China	Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	PFS is defined as time from the start of treatment to progression of disease or death.	up to 3 years
Secondary	Overall Response Rate (ORR)	The rate of participants that achieve either a complete response (CR) or a partial response (PR).	up to 3 years
Secondary	Overall survival (OS)	Overall survival is defined as time from the start of treatment until death due to any reason.	up to 3 years
Secondary	Safety as measured by number and grade of adverse events	Summary adverse events according to NCI-CTCAE 4.03	up to 3 years