eligibility_summary
Eligible: adults 18–70, ECOG 0–1, path-confirmed colorectal adenocarcinoma with peritoneal metastases (>10 cm from anus), clinical M1c, no neoadjuvant therapy, R0 resection, adequate organ function, consented. Exclude: TNF allergy, fever, active hepatitis/HIV, neuropathy, pregnancy/breastfeeding or no contraception, prior malignancy, uncontrolled heart disease, autoimmune disease, substance abuse, major neuro/psychiatric disorders, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study of hyperthermic intraperitoneal perfusion after colorectal cancer resection. Interventions: 1) rmhTNF (recombinant modified human TNF-α) delivered intraperitoneally under hyperthermia, 2) subsequent intraperitoneal raltitrexed 2.5 mg/m2, followed by standard postoperative systemic chemotherapy per guidelines. Drug types/mechanisms: rmhTNF is a cytokine immunotherapy that activates TNFR1/TNFR2 on tumor and tumor-associated endothelial cells, inducing apoptosis/necrosis, disrupting tumor vasculature, increasing vascular permeability, and enhancing local immune responses, hyperthermia augments penetration and cytotoxicity. Raltitrexed is an antimetabolite that inhibits thymidylate synthase, blocking de novo thymidylate synthesis and DNA replication. Targets/pathways: peritoneal micrometastatic tumor cells and implants, tumor endothelial cells, TNF signaling (NF-κB/caspase pathways) and folate-dependent nucleotide biosynthesis via TS.