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

NCT03801668 | Unknown Phase 3

• 1 other identifier: TJCC008
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Albumin-bound Paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Response Rate (ORR)

  up to 3 years

• Overall survival (OS)

  up to 3 years

• Safety as measured by number and grade of adverse events

  up to 3 years

Study Arms (2)

Nab-P/S-1

EXPERIMENTAL

Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.

Drug: Albumin-bound Paclitaxel plus S-1

SOX

ACTIVE COMPARATOR

Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.

Drug: Oxaliplatin plus S-1

Interventions

Albumin-bound Paclitaxel plus S-1 DRUG

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

Nab-P/S-1

Oxaliplatin plus S-1 DRUG

Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.

SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-75 years;
• Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
• At least one measurable lesion as defined by RECIST 1.1 criteria;
• ECOG performance status of 0-1;
• Estimated life expectancy of at least 3 months;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
• 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;
• Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
• Able and willing to comply with the study plans in this protocol and sign the informed consent;

You may not qualify if:

• 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;
• HER-2 positive;
• Patients with symptomatic brain metastases;
• II-IV peripheral neuropathy \[NCI-CTCAE 4.03\];
• Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
• Patients with serious systemic infection or other diseases;
• Allergic to the chemotherapy drugs or the materials in this study;
• Patients with gastrointestinal bleeding that need clinical intervention;
• Patients with digestive tract obstruction or oral nutrition difficulty;
• Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
• Have participated in other clinical trials within 28 days prior to the first dose of this study;
• Contraindications to chemotherapy;
• Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• Dai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022.

  PMID: 35983025 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound Paclitaxel; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Xianglin Yuan, MD,PhD

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Xianglin Yuan, MD,PhD

CONTACT

8627-83663406; xlyuan1020@163.com

Hong Qiu, MD,PhD

CONTACT

8627-83663406; tjqiuhong@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the cancer center

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 11, 2019
• Study Start: March 8, 2019
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: January 4, 2022

Record last verified: 2022-01

Locations

CN (1)