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A Phase II Trial of Biweekly Nab-PaclitaXel in Combination with Ramcirumab for metastatic Gastric Cancer or Gastro-oesophageal Junction Adenocarcinoma

A Phase II Trial of Biweekly Nab-PaclitaXel in Combination with Ramcirumab for Patients with Previously Treated Advanced Gastric Cancer or Gastro-oesophageal Junction Adenocarcinoma(B-RAX trial) (JACCRO GC-09)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031180061
Enrollment
66
Registered
2018-12-21
Start date
2019-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer gastric cancer

Interventions

1st cycle: 28 days per cycle Weekly nab-paclitaxel (100mg/m2, Day1/Day8/Day15) ramucirumab(8mg/kg, Day1/Day15) (1) Patients have not received nab-paclitaxel due to toxicity on day 8 or 15 during 1st c
Not applicable

Sponsors

IZAWA Naoki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (2) age of 20 or more (3) presence of evaluable lesion (4) histopathologically confirmed gastric adenocarcinoma or gastroesophageal adenocarcinoma (5) unresectable or metastatic patients (6) refractory disease or unable to tolerate first line chemotherapy including fluoropyrimidines agents, or refractory disease after or during adjuvant chemotherapy including fluoropyrimidines agents (7) Patients must have the following adequate organ functions (8) Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion criteria: (1)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (2)age of 20 or more (3)presence of evaluable lesion (4)histopathologically confirmed gastric adenocarcinoma or gastroesophageal adenocarcinoma (5)unresectable or metastatic patients (6)refractory disease or unable to tolerate first line chemotherapy including fluoropyrimidines agents, or refractory disease after or during adjuvant chemotherapy including fluoropyrimidines agents (7)Patients must have the following adequate organ functions (8)Ability to understand and the willingness to sign a written informed consent document

Design outcomes

Primary

MeasureTime frame
progression-free survival(PFS)

Secondary

MeasureTime frame
overall survival(OS), response rate(RR), disease control rate(DCR), relative dose intensity, QOL

Contacts

Public ContactNaoki Izawa

St.Marianna University School of Medicine Hospital

n2izawa@marianna-u.ac.jp+81-44-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026