Abstract: Objective To investigate and confirm the clinical efficacy and safety of recombinant mutant human tumor necrosis factorNC （rhTNF-NC，Tianenfu） injection in the treatment of malignant pleural effusion and peritoneal effusion. MethodsIt was a perspective，openlabel，single arm and multi-center study，conducted in 82 cancer centers in China. From April 25 2013 to August 31 2015， a total of 985 patients with middle and large amount of malignant pleural effusion or peritoneal effusion were enrolled into this study. rmhTNFNC was infused intralpeurally at a dose of 300 KU each time at d₁， d₄， d₇， or d₁₀， and 3-4 times was regarded as one course. The efficacy and safety were evaluated according WHO and NCI CTC AE 3.0 criterion respectively. ResultsAmong 985 patients， the efficacy could be evaluated in 916 cases （93.00％） with dropout rate of 7.00％. In 916 patients， the objective response rate （ORR） was 6244％ and disease control rate （DCR） was 97.27％. ORR of 614 malignant pleural effusion cases and 302 malignant peritoneal effusions cases were 70.52％ and 46.03％ respectively（P＜0.05）. Two-classification Logistic regression showed that effusion position， treatment condition （initial treatment vs. retreatment） were independent factors influencing ORR of rmhTNF-NC in the treatment of malignant pleural effusion or peritoneal effusion（P＜0.05）， treatment condition was the independent factor influencing ORR of rmhTNF-NC in the treatment of malignant pleural effusion （P＜0.05）， and gender， PS score before treatment and treatment condition were independent factors influencing ORR of rmhTNF-NC in the treatment of malignant peritoneal effusion（P＜0.05）. The major adverse effects （AE） were fever （14.01％） and chill （10.05％）. Other AE included fatigue（1.02％）， pain（0.81％）， constipation（0.61％）， transaminase lift（0.51％），decreased renal function（0.30％）， shortness of breath（0.20％）， rashes（0.20％）and leucopenia（0.20％）. The vast of those AE was in grade 1 or grade 2， and could be reversible. There was no grade 4 AE and drug related death happened. ConclusionrmhTNF-NC injection is effective and safe in control of malignant pleural effusions or peritoneal effusions， especially better in the early treat and malignant pleural effusions patients， with mild and tolerable adverse effects.