Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorChinese Academy of Medical Sciences

About this trial

* To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer * The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level

Eligibility criteria

Qualifiers

age >18 years.

documented gastric adenocarcinoma via histological or cytological examinations;

newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;

no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -

Disqualifiers

a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;

surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;

severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy

a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;

Trial design

Treatments tested in this trial

  • Phase I Dose-finding Study of Sorafenib Study

Treatment groups

No treatment groups listed

Locations

This trial has no locations