Hyperthermic Intraperitoneal Treatment of rmhTNF for CRCPM: Phase II Clinical Trial
Peritoneal Metastases, Colorectal Cancer
About this trial
This is an interventional other trial for Peritoneal Metastases focused on measuring Colorectal Cancer, Peritoneal metastasis
Eligibility Criteria
Inclusion Criteria: Adenocarcinoma of colonic and peritoneal reflexive superior rectum was confirmed by pathology, aged 18-70 years; Body condition score (PS) 0 ~ 1 in the Eastern Tumor Collaboration Group (ECOG); Preoperative clinical stage was M1c; No neoadjuvant therapy was performed; Histopathologically confirmed as peritoneal metastases of colorectal cancer > 10cm from the anus, R0-resected, adenocarcinoma/mucinous adenocarcinoma The functions of vital organs shall meet the following requirements; Be able to understand the situation of this study and sign informed consent. Exclusion Criteria: Allergic history of TNF and its derivatives; Patients with fever (>38℃); Active hepatitis and peripheral neuropathy (e.g., peripheral neuritis, pseudomeningitis, motor neuritis, and sensory disorders); Pregnant or lactating women, or potentially pregnant women and sexually active men who refuse/cannot receive medically acceptable forms of contraception; Patients with a history of malignant tumor; Clinical symptoms or diseases of the heart that are not well controlled. Subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; The subject has a known history of psychotropic substance abuse, alcoholism or drug use; Subjects innate or acquired immune function defects (such as HIV infection), or active hepatitis Other conditions in which the investigator thinks the patient should not participate in the study; A history of neurological or psychiatric disorders, such as major depression or dementia, that may affect the informed study or follow-up evaluation;
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Group1
The preoperative clinical stage was M1c colon or peritoneal retroflex superior rectum adenocarcinoma