Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients (SECOX)

Sanofi

Status and phase

Withdrawn

Phase 3

Conditions

Hepatic Neoplasm Malignant

Treatments

Drug: capecitabine

Drug: sorafenib

Drug: oxaliplatin (SR96669)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01245582

EFC11719

OXALI_R_05123 (Other Identifier)

U1111-1115-8557 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients.

Secondary Objective:

To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS)
To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)
To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone

Full description

For each patient, the study consists of a baseline period of screening up to 2 weeks, a treatment period with 2 weeks as one study treatment cycle.

Each patient will be randomly assigned to receive either SECOX (Sorafenib, Oxaliplatin with Capecitabine) or Sorafenib alone every 2 weeks until disease progression, intolerable toxicity, or patient's refusal of further study treatment. There will be a 30-day follow-up visit after the last study treatment.

All patients will be follow-up every 2 months until death is observed during post-treatment follow-up period.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with histologically or cytologically or clinically diagnosed advanced HCC not amenable to surgical or local treatment. Documentation of original pathology for diagnosis is acceptable if tumor tissue is unavailable at screening.
Signed written informed consent

Exclusion criteria

Clinically diagnosed subjects who did not meet two following criteria:
- cirrhotic patients with focal lesion > 2cm with arterial hypervascularization demonstrated by 2 coincident imaging techniques
- cirrhotic patients with focal lesion > 2cm with arterial hypervascularization demonstrated by 1 imaging technique and associated with Alpha Fetoprotein (AFP) level > 400 ng/mL
Subjects who are receiving or previously received any other investigational therapy or any other systemic anti-cancer treatment for HCC including chemotherapy, immunotherapy or targeted agents, except radiotherapy to non-target lesion (bone metastasis, etc) and HCC adjuvant therapy which was completed more than 6 months prior to randomization. Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to randomization.
Subjects with main portal vein thrombosis.
Subjects with encephalopathy or history of encephalopathy, ascites uncontrolled by medication, active or history of variceal or gastrointestinal bleeding within 30 days
Subjects with Central Nervous System (CNS) metastasis
Subjects without one target tumor lesion that be measurable at baseline according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
Subjects who have received local therapy such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection within 4 weeks prior to randomization
Subjects with Child-Pugh > A
Eastern Cooperative Oncology Group (ECOG) > 2
Subjects with inadequate bone marrow, liver and renal function
Subjects with previous liver transplantation
Subjects with other serious diseases or medical conditions within 6 months that might be associated with a life expectancy of less than 3 months
Subjects with other malignant disease previously or concurrently, except cured basal cell carcinoma of skin, cervical carcinoma in situ or any cancer curatively treated > 3 years prior to study entry
Subjects with known severe hypersensitivity to sorafenib or any other component of sorafenib
Pregnant or lactating women, or women of child bearing potential without contraceptive method or unwilling to take effective contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

SECOX regimen

Experimental group

Description:

Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)

Treatment:

Drug: oxaliplatin (SR96669)

Drug: sorafenib

Drug: capecitabine

Sorafenib alone

Active Comparator group

Description:

Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)

Treatment:

Drug: sorafenib