First Line Chemotherapy for Advanced Cancer (GC-A-003)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Terminated; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: S-1; Drug: albumin-bounded paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01980810

CH-GI-037-nab

Details and patient eligibility

About

The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

Full description

This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
• Adult patients >=18 years of age
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
• At least have one measurable disease(according to RECIST)
• Adequate bone marrow,renal and liver function

Exclusion criteria

• Previous chemotherapy for advanced/metastatic disease
• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

albumin-bounded paclitaxel plus S-1

Experimental group

Description:

arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression

Treatment:

Drug: albumin-bounded paclitaxel

Drug: S-1