A Phase 2 interventional study of Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF) in Peritoneal Metastases and Colorectal Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Other
The goal of this study is planing to adopt intra-abdominal perfusion therapy of rmhTNF during radical colorectal cancer surgery to determine whether intra-abdominal therapy has an impact on postoperative intestinal function recovery, anastomotic leakage, postoperative bleeding, postoperative adhesion intestinal obstruction and other complications. On this basis, the effect of rmhTNF on postoperative peritoneal implantation metastasis and long-term survival was further studied. The main question it aims to answer is: To evaluate the safety and efficacy of rmhTNF in the treatment of peritoneal metastases in colorectal cancer. Participants will receive 1. Radical surgery: Surgical methods can be developed or endoscopic (including robotic surgery). Radical resection of colorectal cancer (corresponding resection of colon and rectum plus regional lymph node dissection, regional lymph node dissection including parenteral, intermediate and mesangial root lymph nodes) follows the principle of mesangectomy and tumorless operation. 2. Abdominal heat perfusion was performed twice: the first time, 5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation; the second time, rhatitrexed 2.5mg/m2 was injected into the abdominal cavity through thermoperfusion or drainage tube; 3. Postoperative systemic chemotherapy regimen: postoperative adjuvant chemotherapy should be started 3-4 weeks after surgery, and appropriately extended for patients with poor physique, but no later than 8 weeks after surgery. The chemotherapy regimen was determined by the clinician according to pathological stage, molecular typing, and risk factors, referring to the NCCN and CSCO guidelines.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 10 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
The preoperative clinical stage was M1c colon or peritoneal retroflex superior rectum adenocarcinoma
Drug: Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)
5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation;
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, the time of postoperative intestinal function recovery, whether exist anastomotic leakage, postoperative bleeding, postoperative adhesion ileus, and other complications in 2 weeks after surgery.
Time frame: 1 year
the recurrence rate of metastasis and long-term survival of participants accepted the treatment of rmhTNF in the treatment of peritoneal metastases in colorectal cancer.
1. record the time period between the date of randomization and the date of patient tumor recurrence or death (earliest occurrence), and calculated the recurrence rate of metastasis after surgery. 2. 1-year overall survival rate after surgery
Time frame: 1 year
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University