NCT05755685

Hyperthermic Intraperitoneal Treatment of rmhTNF for CRCPM: Phase II Clinical Trial

Status unknown Phase 2 Last updated 6 March 2023

What this trial tests

Phase 2 trial testing Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF) in Peritoneal Metastases in 10 participants. Status unknown.

Timeline

10 February 2023

Primary endpoint
1 January 2024

1 January 2025

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	10
Start date	10 February 2023
Primary completion	1 January 2024
Estimated completion	1 January 2025
Sites	1 location across China

Drugs / interventions tested

• Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF) — full drug profile →

Conditions studied

• Peritoneal Metastases — all drugs for Peritoneal Metastases →
• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 70, any sex, with Peritoneal Metastases or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.