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Not yet recruitingNCT07065175Updated Jul 15, 2025

KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury

A Phase 2 interventional study of Kangfupen (liquid dressing) retention enema administration in Chronic Radiation-induced Proctitis, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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. Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment?
  2. Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)?
  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.

Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis:

  1. Change in LENT-SOMA rectal injury score (baseline vs. 3 months).
  2. Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores.
  3. Symptom improvement rate and time to complete remission.

Participant will:

  1. Undergo baseline and 3-month endoscopic evaluations.
  2. Complete symptom diaries and quality-of-life questionnaires.
  3. Attend regular clinic visits for safety monitoring.
Read the detailed description

Baseline Assessments

All enrolled patients must complete the following evaluations:

  1. Medical history including primary tumor type, histopathology, staging and radiotherapy details (timing, technique, and total dose)
  2. Physical examination
  3. ECOG performance status
  4. Laboratory tests including complete blood count, stool occult blood, liver/kidney function and tumor markers
  5. Pelvic scans to exclude tumor recurrence/progression
  6. Full colonoscopy with photographic documentation. Images every 5cm from anus to splenic flexure, and at sites of severe mucosal reaction additionally
  7. Grading based on LENT-SOMA, RTOG, and CTCAE v5.0 criteria

Treatment protocol Kangfupen (liquid dressing) retention enema

  • Dosage: 50 mL once daily for 3-6 months

  • Administration depth: Determined by colonoscopy findings Enema preparation \& administration 1. Reconstitution:

    1. Transfer liquid from plastic to brown glass vial
    2. Shake vigorously to dissolve lyophilized powder
    3. Return solution to plastic bottle and shake again 2. Delivery:

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    1. Position: Left lateral decubitus with waste basin
    2. Slowly instill 50 mL into rectum
    3. Retain for ≥30 minutes, rotating positions every 15 minutes (left/right lateral, supine, knee-chest)

Concomitant therapies Permitted: probiotics, smectite, antibiotics, stool softeners Prohibited: 5-ASA drugs (mesalazine/sulfasalazine), endoscopic hemostasis (e.g., argon plasma coagulation), formaldehyde/HBO/surgery/fecal microbiota transplant, other enema therapies.

Toxicity monitoring Potential adverse events include allergic reactions and mechanical injury (bleeding/perforation). Required Actions include immediately discontinuing treatment and reporting to the principal investigating site within 24 hours.

All adverse events will be assessed using CTCAE v5.0 criteria.

Follow-up schedule Month 1-2: LENT-SOMA, RTOG/CTCAE grades, IBDQ, symptom improvement evaluation Month 3: Above + sigmoidoscopy with Vienna scoring Every 6 months after month 6: sigmoidoscopy + all scales + physician's global assessment of treatment efficacy

02

Conditions studied

  • Chronic Radiation-induced Proctitis

Keywords

  • Radiotherapy complications
  • Chronic radiation-induced proctitis
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Fully voluntary with decision-making capacity
  • 18-80 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    All enrolled patients

    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

  • DrugKangfupen (liquid dressing) retention enema administration

    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)

06

What researchers measure

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

    Time frame: From enrolment to 3 months post-treatment

Secondary outcomes

  1. Change in Vienna endoscopic scores from baseline to post-treatment

    Treatment response is defined as: 1. Effective: Any decrease in Vienna endoscopic score at 3 months post-treatment compared to baseline 2. Ineffective: Stable or increased score compared to baseline

    Time frame: From enrolment to 3 months post-treatment

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

    Treatment response is defined as: 1. Efficient: Any decrease in either RTOG radiation toxicity grade or CTCAE adverse event grade from baseline 2. Inefficient: No improvement or worsening in both grading systems

    Time frame: From enrolment to 3 months post-treatment

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

    Treatment response is defined as: 1. Efficient: Any decrease in IBDQ bowel function and bleeding scores post-treatment compared to baseline 2. Inefficient: No change or increase in IBDQ bowel function and bleeding scores versus baseline

    Time frame: From enrolment to 3 months post-treatment

  4. Post-treatment symptom improvement rate

    Symptoms are categorized into: Complete remission: Complete resolution of clinical symptoms (e.g., rectal bleeding, diarrhea, tenesmus) Partial remission: Significant improvement in symptoms, but not complete resolution Stable disease: No significant change in symptoms (no improvement or worsening) Progression: Worsening of clinical symptoms Treatment response is defined as: 1. Effective: Complete remission or partial remission 2. Ineffective: Stable disease or progression

    Time frame: From enrolment to 3 months post-treatment

Other outcomes

  1. Endoscopic response (Vienna Score)

    Assessment: Change from baseline at each timepoint Response Criteria: Effective: Decreased Vienna score Ineffective: Stable/increased score

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

  2. Toxicity improvement (RTOG/CTCAE)

    Assessment: Grading change from baseline Response Criteria: Effective: Reduced RTOG/CTCAE grade Ineffective: Unchanged/worsened grade

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

  3. Quality of life (IBDQ Bowel Function/Bleeding)

    Assessment: Subscore change from baseline Response Criteria: Effective: Score reduction (symptom improvement) Ineffective: Stable/elevated score

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

  4. Symptom improvement rate

    Categories: Complete Response (CR): Total symptom resolution (RTOG Grade 0) Partial Response (PR): ≥50% symptom reduction Stable Disease (SD): No significant change Progression (PD): Symptom worsening Clinical Benefit: CR + PR Note: For discordant symptoms, the primary symptom (investigator-designated) determines classification.

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

  5. Time to complete symptom resolution

    Time frame: From enrolment to sustained (≥7 days) CR

07

Study locations

1 site
  • Peking Union Medical College Hospital & Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100730, China
    • Weiping Wang, Doctor · Contact · jluwangweiping@163.com · 86-69154081
    • Ke Hu, Doctor · Principal investigator
08

References and documents

Publications

  • 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. PubMed 38705489 ↗
  • 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. PubMed 36199943 ↗
  • 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. PubMed 24113055 ↗
  • 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. PubMed 15093915 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07065175
Lead sponsor
Peking Union Medical College Hospital
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, Beijing Rectum Hospital, Jilin City Hospital of Chemical Industry
Responsible party
Sponsor
First posted
Jul 15, 2025
Start date
Aug 2025 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Jul 15, 2025

Study contacts

Ke Hu, Doctor
Contact
huke8000@126.com
86-010-69155482

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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