GDF15 Based TPF Induction Chemotherapy for OSCC Patients

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Nov 4, 2014

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with a specific type of mouth cancer called squamous cell carcinoma. The researchers want to see how well a drug called GDF15 can predict the effectiveness of an induction chemotherapy regimen known as TPF. This trial is particularly focused on patients with advanced cancer (stages III and IVA) who are eligible for surgery and have high levels of GDF15 in their system.

To participate in this study, you need to be between 18 and 75 years old and have a confirmed diagnosis of squamous cell carcinoma in the mouth. You also need to be in good overall health, which means having a decent level of physical functioning and normal blood, liver, and kidney tests. Participants will receive the TPF chemotherapy treatment and will be monitored closely throughout the study. It's important to note that individuals with certain conditions, like severe heart or lung problems, previous cancer treatments, or pregnant and nursing women, cannot join this trial. If you're interested in learning more or think you might be eligible, please consult with your healthcare provider.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age: 18 to 75 years old.
• • Sex: both males and females.
• • Karnofsky performance status (KPS) \>60.
• • Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
• • GDF1 high expression
• • Clinical stage III/IVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\[international Union Against Cancer \] 2002) with resectable lesions.
• • Adequate hematologic function: white blood cell \>3,000/mm3, hemoglobin\>8g/L, platelet count\>80,000/mm3.
• • Hepatic function: ALAT(alanine aminotransferase)/ASAT(aspartate transaminase) \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 times ULN.
• • Renal function: serum creatinine \<1.5 times ULN.
• • Written informed consent
• Exclusion Criteria:
• • Evidence of distant metastatic disease and other cancers.
• • Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
• • Previous radiotherapy or chemotherapy.
• • Other previous malignancies within 5 years.
• • Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
• • Legal incapacity or limited legal capacity.
• • Creatinine clearance \<30ml/min.
• • Pregnancy (confirmed by serum or urine β-HCG) or lactation period.