Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: Paclitaxel + S-1 + Oxaliplatin

• Registration Number: NCT03263741
• Lead Sponsor: Affiliated Hospital of Qinghai University

Brief Summary

Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer

Detailed Description

To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Primary Completion: 2019-09-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
2. Locally advanced, or recurrent, or metastasis disease；
3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed;
4. Life expectancy of at least 3 months;
5. ECOG score 0-1;
6. Age: 18~70 years old;
7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl;
8. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases;
9. Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver);
10. Not participating in other study projects before and during the treatment;
11. Voluntarily signed the informed consent.

Exclusion Criteria

1. Previously treated with first-line chemotherapy;
2. Allergy to the drugs in this protocol;
3. Pregnant or lactating women;
4. Women at childbearing age and of pregnancy desire during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel + S-1 + Oxaliplatin group	Paclitaxel + S-1 + Oxaliplatin	Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) \< 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to \< 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.

Primary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	2 years	The sum of complete remission (CR) rate and partial remission (PR) rate.

Secondary Outcome Measures

Name	Time	Method
Disease control rate(DCR)	2 years	The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year
Progression-free survival(PFS)	2 years	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival(OS)	2 years	From date of enrollment until the date of death from any cause, assessed up to 60 months

Trial Locations

Locations (1)

Affiliated Hospital of Qinghai University; 🇨🇳 Xining, Qinghai, China