The clinical trials for safety and usefulness of chronic hepatitis therapeutics,agent 3-oxygelmillpropionic acid polymer for the advanced and recurrent colorectal cancer of having the existing chemotherapeutic refractory or intolerance.(Phase 1 test)

The clinical trials for safety and usefulness of chronic hepatitis therapeutics,agent 3-oxygelmillpropionic acid polymer for the advanced and recurrent colorectal cancer of having the existing chemotherapeutic refractory or intolerance.(Phase 1 test) - Propagermanium test

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022129

Enrollment

Registered

2016-04-28

Start date

2016-05-16

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

The advanced and recurrent colorectal cancer of having the refractory or intolerance of existing chemotherapy

Interventions

The dose of Seroshion is 1 capsule (10mg) /time after each meal (3 times/day,30mg/day). The administration period is six months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)The patients who obtained the written consent before performing the various procedures for the test. Patients who can understand and are willing to sign the contents of the consent document.(2) The case who was diagnosed histologically colorectal cancer and was decided to be unresectable by the distant metastases or locally advanced. (3)The patients who have intolerance of standard chemical treatment and were exacerbated within 3 months from the last administration,fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and anti-EGFR antibody drugs (cetuximab or panitumumab).(4)The age is over 20 years old.(5)PS (ECOG) is 0 or 1. (6)3 months or more survivor.(7)The patients can eat orally.(8)Within 14 days before,major organ function is held by clinical examination.(a)WBC is above 3,000 / mm3 and below 12,000/mm3,b)Neu is above 1,500/mm3,c)Plt is above 100,000/mm3, d)Hb is above 8.0g / dL,e)T-bil is below 2.0mg/dL,f) AST (GOT) is below 100IU / L,g) ALT (GPT)is below 100IU/L,h) Cr is below 1.2mg/dL(8)The patients who consent by the document.

Exclusion criteria

Exclusion criteria: (1)Patients with active double cancer.(2)Patients with serious drug hypersensitivity or with a history of drug allergy.(3)Patients with serious complications.(4)Patients with jaundice,cirrhosis or with suspected cirrhosis of the liver.(5)There is a history of chronic hepatitis B, and in the present study drug has already been ingested.(6)Patients with active infection.(7)Women who have a possibility of or in the pregnancy,who hope to become pregnant,or who are breast-feeding. Men who wish to become pregnant partner.(8)Patients with severe mental disorder.(9Other patients whom the physician decided to be unsuitable for safely carrying out the present study.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Efficacy and pharmacokinetics	—

Countries

Japan

Contacts

Public ContactMamoru Uemura

Osaka University,Graduate School of Medicine Gastroenterological Surgery

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

Outcome results

None listed

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