CClinicalTrials.gg
Status unknownNCT01747642Updated Dec 12, 2012

Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

A Phase 2/3 interventional study of Oncoxin and Suranix in Quality of Life, sponsored by Clinical Research Organization, Dhaka, Bangladesh. Status unknown at 1 site in Bangladesh. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-12-12.

Sponsored by Clinical Research Organization, Dhaka, Bangladesh · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)

Read the detailed description

To assess therapeutic efficacy and safety of Oncoxin plus Surafenib in hepatocellular carcinoma

To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

To see if there is improved survival in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib

02

Conditions studied

  • Quality of Life

Keywords

  • Hepatocellular carcinoma
  • Oncoxin
  • Surafenib
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Clinical Research Organization, Dhaka, Bangladesh is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
  • Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
  • Patients with HCC who have evidence of tumor metastasis
  • Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
  • Patients with HCC in whom all possible treatment options have been exhausted.

Exclusion criteria

Exclusion Criteria:

  • Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
  • Patients with HCC who have no evidence of tumor metastasis
  • Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
  • Patients with HCC who are voluntarily unwilling to be included in the trial
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Oncoxin

    Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days

    Dietary Supplement: Oncoxin

  • Active comparator
    Oncoxin & Suranix

    Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days

    Dietary Supplement: Oncoxin · Drug: Suranix

  • No intervention
    Supportive treatment

    Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out.

Interventions

  • Dietary supplementOncoxin

    Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days

  • DrugSuranix

    Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days

    Also known as: Nexavar, Suranib

06

What researchers measure

Primary outcomes

  1. Number of patients who have prolonged survival

    To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Reduction in serum alpha-fetoprotein level and decrease in tumor size

    To see whether Oncoxin plus Surafenib results in reduction in serum alpha-fetoprotein level in ng/ml and decrease in tumor size in mm in hepatocellular carcinoma patients off treatment for 24 weeks, after receiving Oncoxin plus Surafenib for 24 weeks.

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Farabi General Hospital
    Dhaka, 1215, Bangladesh
    • Mamun A Mahtab, MD, FACG · Contact · shwapnil@agni.com · +8801711567275
    • Helal Uddin, BSc · Contact · crobangladesh@gmail.com · +880-1819251514
    • Mamun A Mahtab, MD, FACG · Principal investigator
    • Lovely Begum, BPharm · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01747642
Lead sponsor
Clinical Research Organization, Dhaka, Bangladesh
Responsible party
Sponsor
First posted
Dec 12, 2012
Start date
Dec 2012
Primary completion
Dec 2013 (estimated)
Completion
Jun 2014 (estimated)
Last update
Dec 12, 2012

Study contacts

Mamun A Mahtab, MD, FACG
principal investigator · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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