A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies

A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies - A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies(T-SCAN study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031346

Enrollment

Registered

2018-02-28

Start date

2018-02-28

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

advanced gastric cancer refractory to standard chemotherapies

Interventions

Level 1a TAS-102: 35 mg/m2 twice daily, after the morning and evening meal, for 5 days a week with 2 days rest for 2 weeks, followed by a 14-day rest. Irinotecan: 100mg/m2/day, administered by intra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients are Japanese patients aged >=20 years with: - Histological confirmation of advanced gastric adenocarcinoma - Patient with oral intake - ECOG performance score of 0 or 1 - Patients with measurable lesions - Disease refractory to fluoropyrimidine, platinum and taxane. - Adequate organ function as defined by the following criteria: 1.Absolute neutrophil count (ANC) >= 1,500/ul 2.Platelets >= 100,000/ul 3.Hemoglobin >= 8.0 g/dl 4.AST and ALT <= 2.5 x ULN (without known liver metastasis), <= 5.0 x ULN (with known liver metastasis) 5.Total bilirubin <= 1.5 mg/dL 6.Serum creatinine <= 1.5 mg/dL 7.PT- INR <= 1.5 8.Diarrhea <= Grade 1 9.UGT1A1*6*28 wild type or single hetero - Written informed consent

Exclusion criteria

Exclusion criteria: - With a treatment history of TAS-102 or irinotecan - Serious illness such as brain metastasis, systemic infection or gastrointestinal bleeding - Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks - Adverse events due to prior chemotherapy - Administration of blood transfusion or G-CSF within 2 weeks - Severe pulmonaly disorder - Thromboembolism (grade3 or higher) within 6 months - Inappropriate for the study in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Phase I part: the incidence of dose limiting toxicities (DLTs) in each level. Phase II part: Disease control rate (DCR)	—

Secondary

Measure	Time frame
Phase I part: the incidence of adverse events Phase II part: Overall response rate (ORR), Overall survival (OS), Progression-free survival (PFS), safety	—

Countries

Japan

Contacts

Public ContactTakuro Mizukami

St. Marianna University School of Medicine Hospital Department of Clinical oncology

t3mizukami@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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