The study is to check the duration of response of Capecitabine and Erlotinib combination after the 1st line chemo therapy of sorafenib in advanced Hepatocellular Carcinoma ( Liver Cancer)
- Conditions
- Health Condition 1: C227- Other specified carcinomas of liver
- Registration Number
- CTRI/2021/01/030657
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects must provide written informed consent prior to the performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures.
2.Histological or cytological confirmation of HCC (hepatocellular carcinoma) or radiologically confirmed diagnosis of HCC as per American Association for the Study of Liver Diseases criteria in patients with a confirmed diagnosis of cirrhosis.
3.Failure to prior treatment with Sorafenib (defined as clinical or radiological progression) or experiencing grade 3/4 toxicities on Sorafenib.
4.Barcelona Clinic Liver Cancer stage Category B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation or chemoembolization.
5.Liver function status Child-Pugh (CTP) score <=7. (Child Pugh status will be calculated based on clinical findings and laboratory results during the screening period).
6.Local or loco-regional therapy of intrahepatic tumour lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >=4 weeks before first dose of study medication.
7.Age18 years or older with Eastern Cooperative Oncology Group Performance Status of 0 to 2.
8.Participants must have normal organ and marrow function as defined below within 15 days before starting study medication:
â??Neutrophils>=1,500/mcL
â??Platelets>=60,000/mcL
â??Haemoglobin >=8.0 g/dl
â??Total bilirubin<=3 Ã? institutional upper limit of normal
â??AST(SGOT)/ALT(SGPT) <= 3 Ã? institutional upper limit of normal
â??Albumin levels of >= 2.5 mg/dl
â??Calculated Creatinine clearance >= 30 ml/min
9.At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC. Tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
10.Life expectancy of at least 3 months.
11.Negative serum pregnancy test (if applicable) and willing for adequate contraception
1.Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 5.0. Hepatitis B and Hepatitis C will be allowed.
2.Fibrolamellar hepatocellular carcinoma.
3.Patients unable to swallow oral medications.
4.Patients has pulmonary fibrosis, or pulmonary interstitial disease.
5.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
6.History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis. Screening with CNS imaging studies computed tomography or magnetic resonance imaging is required only if clinically indicated.
7.Known hypersensitivity or contraindications against erlotinib or capecitabine.
8.Patients with a history of liver transplant; gastric varices not amenable to ablative therapy; ascites or encephalopathy refractory to medical management; bleeding from esophageal or gastric varices during the 3 months before study participation or other poorly controlled medical conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) will be defined as the time from enrollment to the time of disease progression or death, or to the date of last tumor assessment without any such event (censored observation). <br/ ><br>Timepoint: 36 months
- Secondary Outcome Measures
Name Time Method 1)Overall survival (OS) <br/ ><br>2)Quality of Life (QOL) <br/ ><br>3)Progressive disease (PD) <br/ ><br>4)Complete response <br/ ><br>5)Partial response <br/ ><br>6)Stable disease (SD) <br/ ><br>7)Objective response rate (ORR) <br/ ><br>8)Disease control (DC)Timepoint: 36 months