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Phase II study of DCS-T

Phase II study of S-1, docetaxel, cisplatin and trastuzumab combination chemotherapy (DCS-T) in patients with HER2-positive unresectable metastatic gastric cancer - Phase II study of DCS-T

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061180096
Enrollment
30
Registered
2019-03-22
Start date
2020-02-16
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

Docetaxel (50mg/m2) and CDDP (60mg/m2), S-1 (80mg/m2) and trastuzumab (6mg/kg) given on day 8, and S-1 (80mg/m2) given on days 1-14, repeated every three weeks.

Sponsors

Takayama Tetsuji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Written informed consent. 2)Histologicaly (cytologically) proven gastric cancer. 3)HER2 positive by IHC or FISH method 4)Unresectable gastric cancer. 5)To have measurable lesions. 6)No prior chemotherapy or no influence of prior therapy. 7)Tolerable function of bone marrow, liver and kidney. 8)LVEF more than 50% 9)PS 0 - 1. 10)Expected survival for 3 months. 11)Possible oral intake.

Exclusion criteria

Exclusion criteria: 1)History of hypersensitivity to DCS. 2)Contraindication to TXT, CDDP, S-1, G-CSF. 3)Infectious disease. 4)Severe compliaction. 5)Brain metastasis with clinical symptoms. 6)Watery diarea. 7)Active double cancer. 8)Persons to be pregnant or to make pregnant.

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
median survival time (OS), progression-free survival(PFS)

Contacts

Public ContactYasushi Sato

Tokushima University

sato.yasushi@tokushima-u.ac.jp+81-88-633-7124

Outcome results

None listed

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