Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

NCT ID: NCT01747642

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Quality of Life

Keywords

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Hepatocellular carcinoma Oncoxin Surafenib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oncoxin

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

Group Type ACTIVE_COMPARATOR

Oncoxin

Intervention Type DIETARY_SUPPLEMENT

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

Oncoxin & Suranix

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

Group Type ACTIVE_COMPARATOR

Oncoxin

Intervention Type DIETARY_SUPPLEMENT

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

Suranix

Intervention Type DRUG

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

Supportive treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oncoxin

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

Intervention Type DIETARY_SUPPLEMENT

Suranix

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

Intervention Type DRUG

Other Intervention Names

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Nexavar Suranib

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Organization, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mamun A Mahtab, MD, FACG

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

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Farabi General Hospital

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Facility Contacts

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Mamun A Mahtab, MD, FACG

Role: primary

Helal Uddin, BSc

Role: backup

Other Identifiers

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OP2

Identifier Type: -

Identifier Source: org_study_id