A trial of ramucirumab plus paclitaxel combined therapy for elderly gastric cancer patients

JRCT ID: jRCT1031200158

Registered date:15/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: refractory to first-line treatment
• Date of first enrollment: 01/05/2016
• Target sample size: 35
• Study type: Observational

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Response rate, Overall survival, Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. adenocarcinoma
2. unresectable or recurrent gastric cancer
3. PD after first-line treatment
4. No massive ascites
5. No metastasis for central nervus system
6. Sufficient oral intake
7. 70 years or more
8. ECOG performance status; grade 0, 1

Exclude criteria

1. Uncontrollable diabetes mellitus
2. VTE (DVT, PE)
3. Myocardial infaction
4. Cerebrovascular disease
5. GI tract bleeding within 3 months
6. GI tract perfooration
7. Uncotrollable hypertension
8. Patients with inadquate performance status

Related Information

• Primary Sponsor: Kunisaki Chikara