KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

NCT07065175 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PUMCHKANGFUPENG
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are:

1. 1.Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment?
2. 2.Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)?
3. 3.What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location.
4. 4.Change in LENT-SOMA rectal injury score (baseline vs. 3 months).
5. 5.Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores.
6. 6.Symptom improvement rate and time to complete remission.
7. 7.Undergo baseline and 3-month endoscopic evaluations.
8. 8.Complete symptom diaries and quality-of-life questionnaires.
9. 9.Attend regular clinic visits for safety monitoring.

Conditions

Chronic Radiation-induced Proctitis

Keywords

Radiotherapy complications; Chronic radiation-induced proctitis

Outcome Measures

Primary Outcomes (1)

• Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment

  Treatment response is defined as: 1. Effective: Decrease in LENT-SOMA score compared to baseline 2. Ineffective: No change or increase in LENT-SOMA score versus baseline

  From enrolment to 3 months post-treatment

Secondary Outcomes (4)

• Change in Vienna endoscopic scores from baseline to post-treatment

  From enrolment to 3 months post-treatment

• Changes in RTOG and CTCAE grading from baseline to post-treatment assessments

  From enrolment to 3 months post-treatment

• Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Function and Bleeding Scores from baseline to post-treatment

  From enrolment to 3 months post-treatment

• Post-treatment symptom improvement rate

  From enrolment to 3 months post-treatment

Other Outcomes (5)

• Endoscopic response (Vienna Score)

  From enrolment to 6, 12, 24, 36 months post-treatment

• Toxicity improvement (RTOG/CTCAE)

  From enrolment to 6, 12, 24, 36 months post-treatment

• Quality of life (IBDQ Bowel Function/Bleeding)

  From enrolment to 6, 12, 24, 36 months post-treatment

Study Arms (1)

All enrolled patients

EXPERIMENTAL

All enrolled patients receive the same investigational intervention (Kangfupen liquid dressing enema). Scientific comparison is achieved through Pre- vs. post-treatment (3/6/12mo) parameter changes (e.g., ΔLENT-SOMA).

Drug: Kangfupen (liquid dressing) retention enema administration

Interventions

Kangfupen (liquid dressing) retention enema administration DRUG

Dosage: 50 mL per administration, once daily Duration: 3-6 months of continuous therapy Procedure: Enema depth determined by colonoscopy-identified lesion location Administered as retention enema (minimum 30-minute retention time)

All enrolled patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully voluntary with decision-making capacity
• years old
• Completed pelvic radiotherapy for malignancy ≥3 months prior
• Evidence of chronic radiation-induced rectal injury (RTOG Grade ≥2)
• Evidence of radiation-induced rectal injury on colonoscopy (within 3 months, Vienna endoscopic score ≥1)
• No prior surgery
• ECOG score 0-2
• Estimated survival ≥1 year

You may not qualify if:

• Primary rectal tumours or pelvic malignancies with rectal involvement
• Uncontrolled, recurrent, or metastatic tumours
• Concurrent anticancer therapies including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine with anti-tumour properties
• Patients with intestinal fistula, perforation, or obstruction
• History of electrocautery treatment within 1 month
• Recent medication use (within 2 weeks): traditional Chinese medicine enemas, mesalazine (oral or rectal) and other anti-inflammatory bowel medications
• History of superoxide dismutase allergy
• Pre-existing chronic colitis, ulcerative colitis, or nonspecific proctitis
• Connective tissue diseases requiring long-term corticosteroid therapy
• Pregnant or lactating women
• Active infection or fever
• Other severe comorbidities potentially affecting trial compliance: unstable cardiac disease requiring treatment, renal disorders, chronic hepatitis, poorly controlled diabetes and psychiatric illnesses

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Peking University First Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Beijing Rectum Hospital: collaborator
• Jilin City Hospital of Chemical Industry: collaborator

Study Sites (1)

Peking Union Medical College Hospital & Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (4)

• Zhu J, Li X, Huang M, Zhu H, Tan Y, He X, Sun Z, Cheng H, Li F, Jiang P, Lou H, Ke G, Cao X, Zhu L, Xie P, Yan J, Zhang F. Application of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Acute Rectal Injury: A Multicenter, Randomized, Open-label, Prospective Trial. Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):720-729. doi: 10.1016/j.ijrobp.2024.04.070. Epub 2024 May 4.

  PMID: 38705489 BACKGROUND

• Tohidinezhad F, Willems Y, Berbee M, Limbergen EV, Verhaegen F, Dekker A, Traverso A. Prediction models for brachytherapy-induced rectal toxicity in patients with locally advanced pelvic cancers: a systematic review. J Contemp Brachytherapy. 2022 Aug;14(4):411-422. doi: 10.5114/jcb.2022.119427. Epub 2022 Aug 31.

  PMID: 36199943 BACKGROUND

• Michalski JM, Yan Y, Watkins-Bruner D, Bosch WR, Winter K, Galvin JM, Bahary JP, Morton GC, Parliament MB, Sandler HM. Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):932-8. doi: 10.1016/j.ijrobp.2013.07.041. Epub 2013 Oct 8.

  PMID: 24113055 BACKGROUND

• Wang CJ, Huang EY, Sun LM, Chen HC, Fang FM, Hsu HC, Changchien CC, Leung SW. Clinical comparison of two linear-quadratic model-based isoeffect fractionation schemes of high-dose-rate intracavitary brachytherapy for cervical cancer. Int J Radiat Oncol Biol Phys. 2004 May 1;59(1):179-89. doi: 10.1016/j.ijrobp.2003.10.025.

  PMID: 15093915 BACKGROUND

Central Study Contacts

Ke Hu, Doctor

CONTACT

86-010-69155482; huke8000@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The efficacy assessment employs a repeated-measures design with intra-individual comparisons between baseline and post-treatment timepoints.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 15, 2025

Record last verified: 2025-05

Locations

CN (1)