Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCC

Exclusion Criteria

• •Patients who do not give their written informed consent to participate in the study.
• •Patients with less common RCC subtypes, such as pure papillary cell tumours, Bellini carcinoma, medullary carcinoma or the oncocytic chromophobes and sarcomatoid variants, will be excluded from the study.
• •Patients that have received previous treatment with chemotherapy or that had tumours that evolved during or after immunotherapy treatment.
• •Patients that, due to their characteristics, may obtain a potential benefit from immunotherapy treatment.
• •Patients that have received previous anti-angiogenic treatment.
• •High-risk patients according to Motzer's classification.
• •Concomitant treatment with another chemotherapy or immunotherapy.
• •Arterial uncontrolled hypertension, which is defined as a systolic arterial pressure value \> 150 mmHg or diastolic arterial pressure value \> 90 mmHg, despite adequate medical treatment.
• •Patients with a primary cancer diagnosis different from RCC, except in situ cervical carcinoma, baseline cellular carcinomas or superficial bladder tumours, prostate cancer pT1 gleason \< 6 or other malign tumours which have received curative treatment \> 5 years previous to the inclusion in this study.
• •Cardiac arrhythmia antecedents, that require treatment with anti-arrhythmics (except for beta-blockers or digoxin), symptomatic coronary disease or ischemia (myocardial infarction in the previous 6 months) or congestive cardiac insufficiency \> New York Heart Association (NYHA) class II
• •Patients with active bacterial or fungal infectious processes, which are considered severe from the clinical point of view (≥ Common Terminology Criteria from the National Cancer Institute \[CTC from NCI\] grade 2, version 3)
• •Patients that present previously known positive serology for HIV or chronic hepatitis B or C.
• •Antecedents of organ allograft.
• •Meningeal carcinomatosis or symptomatic uncontrolled cerebral disease.
• •Patients with epileptic disorders that require medication (such as antiepileptics).
• •All unstable conditions that could put the patient's security and/or his study accomplishment in danger.
• •Abuse of substances, clinical conditions, psychological or social, that may interfere with the patient's participation in the study or with the evaluation of the study's results.
• •Patients that present any contraindication or allergy to the study's investigational product.
• •Patients that are participating or that have participated in any clinical trial in the 4 weeks previous to inclusion.
• •Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.