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Clinical trials for the safety and efficacy of the combination of XELOX,the colorectal cancer radical resection adjuvant chemotherapy and of chronic hepatitis therapeutic agent 3 oxygelmillpropionic acid polymer.(Phase 1 test)

Clinical trials for the safety and efficacy of the combination of XELOX,the colorectal cancer radical resection adjuvant chemotherapy and of chronic hepatitis therapeutic agent 3 oxygelmillpropionic acid polymer.(Phase 1 test) - Seroshion test (adjuvant chemotherapy)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022440
Enrollment
5
Registered
2016-06-01
Start date
2016-05-26
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

Colorectal cancer

Interventions

The dose of Seroshion is 1 capsule (10mg) after each meal,three times a day.We start the Seroshion administration at the first day of the chemotherapy,and also continue to intake it ,if you don&#39
t continue the chemotherapy. The end of chemotherapy is the end of Seroshion.

Sponsors

Osaka University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed histologically colorectal cancer. 2)Curative resection,R0 was performed. 3)Patients are diagnosed pathological Stage3 at the postoperative time. 4)20 years older. 5)PS is 0 or 1. 6)Patients who don't receive the treatment except surgery. 7)Oral ingestion is possible. 8)Major organ function is checked by the clinical examination within 14 days. 9) Patients who can receive the treatment within postoperative 8 weeks. 10)The written consent is obtained.

Exclusion criteria

Exclusion criteria: 1) Patients who could not resect curatively. 2) Patients with active double cancer. 3) Patients with severe drug hypersensitivity, or with a history of drug allergy. 4) Patients with serious complications (heart failure, renal failure, liver failure, bleeding ulcer, watery diarrhea, intestinal paralysis, intestinal obstruction, severe diabetes). 5)Patients of cirrhosis with jaundice or of suspected cirrhosis of the liver. 6)Patients with the history of chronic hepatitis B and with the experience of Seroshion. 7)Patients with active infection. 8)Women with the possibility of pregnancy,during pregnancy,with the hope of pregnancy,or with breast-feeding. 9)Patients with mental severe disorder. 10)Other cases who doctor determines that patients are unsuitable for safely carrying out the present study.

Design outcomes

Primary

MeasureTime frame
safety

Countries

Japan

Contacts

Public ContactMizushima Tsunekazu

Osaka University,Graduate School of Medicine Gastroenterological Surgery

tmizushima@gesurg.med.osaka-u.ac.jp0668793251

Outcome results

None listed

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