1. Clinical Trial
Phase IV clinical study of rmhTNF-NC (TianEnFu) in treating malignant tumors
2. Background Information
A multi-center study on the safety and efficacy of rmhTNF-NC (TianEnFu) in treating malignant tumors is conducted in 80-100 hospitals in Nanjing, Beijing, Shanghai, Hangzhou, Guangzhou and Fujian, etc. so 2,000 patients with malignant tumors can benefit from this study.
Tumor necrosis factor α (TNF-α) is the most potent anti-tumor cytokine to date, and is the only cytokine that directly kills tumor cells. Marketed in 2004, rmhTNF-NC is an upgraded product after structural modification of TNF-α with a positive effect on non-small cell lung cancer (NSCLC) and non-Hodgkin's lymphoma when using it with chemotherapy.
3. Study Objective of NSCLC Group
Clinical Trial Center of Fuda Cancer Hospital aims at studying the safety and efficacy of rmhTNF-NC (TianEnFu) in treating NSCLC patients with combination of chemotherapy.
4. Inclusion Criteria
1) Age: 18-70 years old;
2) NSCLC patients; no limit on nationalities and races;
3) Have at least one tumor lesion whose diameter can be measured; MRI scan shows lesion≥20 mm; spiral CT or PET-CT scan shows lesion≥10 mm;
4) Agree to have regular combined chemotherapy
The injection of rmhTNF-NC is given with combined chemotherapy. For example, the cycle of chemotherapy is 21 days. On the 3rd day of chemotherapy, the injection begins and lasts for 5 days (from the 3rd day to 7th day of chemotherapy).
1) The injection of rmhTNF-NC is given to patients in four courses, free in the 1st and 3rd courses and self-funded in the 2nd and 4th courses. The estimated cost of one course is ¥5,000 (actual charges are based on the amount of the drug that patients take);
2) Patients are supposed to pay for chemotherapy, imaging examinations before and after the clinical trial, hospitalization expenses, etc.
1) All participants should be hospitalized in the South Campus of Guangzhou Fuda Cancer Hospital during the treatment;
2) All subjects must strictly sign ICF (informed consent form) and provide some key information such as ID number;
3) Only NSCLC patients can be admitted to our center.
8. Contact Number
If you want to know more about the clinical trial, please contact us:
+86 18922261712 James
+86 18922219082 Mr. Max
+63 9177753426/+86 18922150287 Mr. Segundo Cruz III
+62 81385488989 / +62 87885333001 Dr. Liu Zhengping
+60 195045919 / +86 18922153703 Ms. Rainbow
+86 18922212913 / +66 942211169 Ms. Kanda
+91 9579622244 / +91 22 40036264 / +86 18922153602 Dr. Anup Aboti
+86 18922212969 Ms. Yen
+86 18620846914 / +86 2038993961 / +86 13688859698 Mr. Massoud