A Phase I/II Study of S-1 in Combination with Sorafenib in Patients with Metastatic Renal Cell Cancer.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220941

Enrollment

Registered

2009-12-17

Start date

2009-12-17

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

Renal cell cancer

Interventions

investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) , Sorafenib INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium, sorafenib Thera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with renal cell carcinoma metastases who underwent nephrectomy(with histological confirmation) 2)Patients had not received previous treatment for renal cell carcinoma. Or patients had progressed after one cytokine therapy

Exclusion criteria

Exclusion criteria: 1)Patients with active peptic ulcer 2)Patients with skin disease under medical treatment 3)Patients with uncontrolled hypertension 4)Patients with diarrhea 5)Patients with brain metastases 6)Patients with multiple carcinoma

Design outcomes

Primary

Measure	Time frame
Efficacy and safety Estimation of MTD and RD in Step 1 and estimation of response rate administered at RD in Step 2.	—

Secondary

Measure	Time frame
Efficacy and safety Adverse events, adverse drug reactions, pharmacokinetics and antitumor effect	—

Outcome results

None listed

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