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

Primary Purpose

Peritoneal Metastases, Colorectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peritoneal Metastases focused on measuring Colorectal Cancer, Peritoneal metastasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Group1

Arm Description

The preoperative clinical stage was M1c colon or peritoneal retroflex superior rectum adenocarcinoma

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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. 1-year overall survival rate after surgery

Full Information

First Posted
February 7, 2023
Last Updated
March 2, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai Weike Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05755685
Brief Title
Hyperthermic Intraperitoneal Treatment of rmhTNF for CRCPM: Phase II Clinical Trial
Official Title
Hyperthermic Intraperitoneal Treatment of Recombinant Modified Human Tumor Necrosis Factor (rmhTNF) for Colorectal Cancer With Peritoneal Metastases: Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai Weike Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Metastases, Colorectal Cancer
Keywords
Colorectal Cancer, Peritoneal metastasis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group1
Arm Type
Experimental
Arm Description
The preoperative clinical stage was M1c colon or peritoneal retroflex superior rectum adenocarcinoma
Intervention Type
Drug
Intervention Name(s)
Hyperthermic intraperitoneal treatment of recombinant modified human tumor necrosis factor (rmhTNF)
Intervention Description
5 million IUrmhTNF, dissolved in 30-50ml normal saline, was intraperitoneal heat perfusion into the surgical focus after the operation;
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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. 1-year overall survival rate after surgery
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lifeng Sun, Dr.
Phone
139 5810 3041
Email
sunlifeng@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lifeng Sun, Dr
Organizational Affiliation
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lifeng Sun, Dr.

12. IPD Sharing Statement

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

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