Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Peking Union Medical College Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A total of 520 cases will be randomly divided into Kang Fu Pen (liquid dressing) enema intervention group (experimental group) and non-enema intervention group (control group), according to the ratio of 1:1.

Research Team

Eligibility Criteria

Inclusion Criteria

The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment;

Age ≥18 years old and ≤65 years old;

Pathologically confirmed cervical cancer;

Treatment Details

Interventions

• KANG FU PEN (Other)

Participant Groups

Group I: test group Experimental Treatment 1 Intervention

Intervention:Anti-radiation spray (liquid dressing)

Group II: control group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Peking Union Medical College Hospital

Lead Sponsor

Trials

1,170

Recruited

2,461,000+

Shandong Cancer Hospital

Collaborator

Trials

4

Recruited

43,300+

Sun Yat-sen University

Collaborator

Trials

1,688

Recruited

4,542,000+

Sun Yat-sen

Sun Yat-sen University

Chief Executive Officer since 1925

MD from Hong Kong College of Medicine for Chinese

Zhiwen Yao

Sun Yat-sen University

Chief Medical Officer since 2010

MD from Sun Yat-sen University of Medical Science

Fudan University

Collaborator

Trials

1,280

Recruited

1,719,000+

James Burke

Fudan University

Chief Medical Officer since 2024

MD from UCSF

Ping Zhang

Fudan University

Chief Executive Officer

B.S. in Polymer Science from Fudan University, MBA in Finance from the University of Chicago Booth School of Business

Xiangya Hospital of Central South University

Collaborator

Trials

316

Recruited

1,762,000+

Zhigang Tian

Xiangya Hospital of Central South University

Chief Medical Officer since 2023

MD from Central South University

Liqing Yue

Xiangya Hospital of Central South University

Chief Executive Officer since 2022

PhD in Social Medicine and Health Management from Central South University

Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University)

Collaborator

Trials

1

Recruited

520+

Peking University Third Hospital

Collaborator

Trials

781

Recruited

1,243,000+

Li Shu

Peking University Third Hospital

Chief Medical Officer since 2020

MD

Qiao Jie

Peking University Third Hospital

Chief Executive Officer since 2020

Expertise in Obstetrics and Gynecology

Shandong Cancer Hospital and Institute

Collaborator

Trials

125

Recruited

225,000+

Dr. Yuping Sun

Shandong Cancer Hospital and Institute

Chief Medical Officer since 2022

MD from Shandong Medical University

Prof. Yu

Shandong Cancer Hospital and Institute

Chief Executive Officer

MD from Shandong Medical University

Sichuan Cancer Hospital and Research Institute

Collaborator

Trials

115

Recruited

220,000+

Dr. Wang Yafei

Sichuan Cancer Hospital and Research Institute

Chief Executive Officer since 2023

MD from Sichuan University

Dr. Li Yong

Sichuan Cancer Hospital and Research Institute

Chief Medical Officer since 2023

MD and MPH from China Third Army Medical University

Xijing Hospital Attached Air Force Medical University

Collaborator

Trials

1

Recruited

520+