Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

Clinical Research Organization, Dhaka, Bangladesh

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Quality of Life

Treatments: Dietary Supplement: Oncoxin; Drug: Suranix

Study type: Interventional

Funder types: Other

Identifiers

NCT01747642

OP2

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Oncoxin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Oncoxin

Oncoxin & Suranix

Active Comparator group

Description:

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

Treatment:

Drug: Suranix

Dietary Supplement: Oncoxin

Supportive treatment

No Intervention group

Description:

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